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Index

·                 Software Engineering

·                 Mechanical Engineering

·                 Protein Biochemist

·                 Manufacturing Engineering

·                 Quality Engineering

·                 Engineering Management

·                 Electrical Engineering

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SOFTWARE ENGINEERING

 

 

 

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MECHANICAL ENGINEERING

 

ID#662 - Mechanical Engineer (MEDICAL DEVICE EXPERIENCE REQUIRED)- Location: Research Triangle Park - Salary: up to $80K

 

Medical Device Startup

Position responsibilities include: 

·       overall product concepts,

·       design, development, analysis and testing for an intravascular implantable system and associated catheter tools used in the implant and explant of the device. 

 Specific duties include: 

·       analyze catheter and related mechanical designs and design requirements

·       solid modeling of design systems and subassemblies

·       design, document, and set-up experiments, manage evaluation testing in the laboratory environment.

Requirements

Qualified candidates must possess the following: 

·       BS Degree in Mechanical or Plastics Engineering

·       3 years experience in medical devices

·       experience in 3D solid modeling required

·       experience with catheters, stents, stent delivery systems, surgical tools, vascular introducers, vena cava filters or associated products is required.

 

 

 

ID#661 - Project Engineer - Location: Parsippany, NJ - Salary: up to $95K

 


Manages one or multiple projects for design and validation of products. Designs products that are solutions to user needs through regular interaction with developers, users and company colleagues. He/she must manage all aspects of a given project with timely execution, open communication and efficient use of resources. Engineer must provide knowledge of medical materials, medical device manufacturing and mechanical design as well as be expert in design controls. Travel to view surgical procedures in the operating room must be expected. Create, revise and manage project budgets. Develop intellectual property for company.

Reports to President

Relevant Experience – Ideal candidate will have experience designing orthopedic implants and delivery instruments and be familiar with the 510K and CE marking processes. 2 years industry experience minimum and a results oriented, self directed approach to work required.

Educational Requirements – Candidate will have BSME (MSME preferred).

 

 

ID#660 - Senior Engineer Process & Product Development - Location: Menlo Park, CA - Salary: up to $105K

 

Manages a wide variety of technical tasks and projects involving the development of new products and manufacturing processes.

Duties & Responsibilities:
This individual will be the leader or a key member of companies medical device process and product development teams. The individual’s duties include:

·       Contribute directly to the development of new product concepts, processes, and techniques to ensure that products meet customer’s needs and are high quality and low product.

·       Serve as a technical interface within company between the Manufacturing and Materials, R&D, Quality, Regulatory, and Marketing organizations.

Specific responsibilities include:

·       Manage/hands-on design and development of new products and processes as well as product changes and enhancements.

·       Perform hands-on design and prototyping of BALLON CATHETERS and other related products.

·       Work closely with external partners in the development of new technologies and devices

·       Plan, schedule and complete projects in an aggressive manner.

·       Write test protocols and reports for design verification/process validation, complete testing, and transfer to manufacturing.

·       Contribute in generation of intellectual property and assist in management of companies IP.

·       Supervise assigned engineers, technicians and assemblers.

Qualifications:

·       Bachelor's degree in Mechanical Engineering or related discipline.

·       Minimum of five (5) years of demonstrated leadership in a medical device environment with HIGH-PRESSURE BALLOON CATHETER EXPERIENCE.

·       Ability to manage resources: time, budget, and people. Strong people management skills is essential.

·       Knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO & MDD).

·       Strong written and verbal communication skills to communicate effectively at all levels.

·       Good presentation skills to deliver speeches and/or presentations effectively to a variety of audiences.

·       Hands-on experiences with SolidWorks or ProEngineering modeling software.

·       Proven application of statistics to decipher process validation, process control and design verification testing data.

·       Proven practice of process validation, including use of Design of Experiments (DOE) for process scoping.

·       Medical Device mechanical or electrical engineer with proven product design and problem solving capability.

·       Catheter development and manufacturing experience are a plus

·       Highly motivated individual who works well with all company functions and has a proven track record on leading projects to completion, on-time and within budget

 

 

 

ID#658 - Research and Product Development Engineer – Location: Irvine, CA – Salary: $70K - $90K

 

Medical catheter manufacturer located in the Irvine area has an opening for a talented product development/mechanical engineer to aid in the development of fiber optic laser delivery devices to be used for a variety of surgical procedures.  A hands-on, technical problem solver with a positive, can-do attitude and the ability to wear multiple hats is highly desired.   

 

Responsible for the design, development, documentation, testing, release, and manufacturing support from concept to obsolescence, of finished medical devices.  Ensure medical devices are designed, developed, documented, tested, and released according to applicable FDA, ISO, EN, and other international standards, regulations, and company procedures. 

 

Qualified candidates will possess the following:

* B.S. degree in mechanical engineering,

* At least two years of product development experience in the medical device   industry

* Hands-on technical problem solving ability

* Strong desire to both contribute and learn in a cross-functional team environment

* First-rate 3D-modeling skills,

* Excellent  verbal and written communications skills

 

 

 

 

ID#657 – Principal Engineer PTCA Balloon Catheter – Location: Irvine, CA – Salary: up to $125K

 

Company offers a wide variety of interventional devices for use in treatment and diagnoses of heart and abdominal diseases. By conducting extensive joint R&D activities with physicians to determine new requirements in medical treatment, we are able to implement products based on completely new ideas to improve the QOL (Quality Of Life) of patients.

Job Description
This position will be responsible for research and development of PTCA Balloon Catheter in Santa Ana California. This position must also be able and willing to spend extended period of time at parent company in Japan or Thailand.

Responsibilities
- Participate in engineering work and applied research, development, and design of PTCA Balloon Catheter development
- Perform analysis, testing and integration of required components, assemblies, or systems to meet product requirements
- Produce production ready documentation and support the transition of the product into manufacturing
- Production and quality support for technical issue resolution
- Create and communicate project plans and tasks and manage time to meet project deadlines
- Interfaces with physician(s) on their expectations for using operations and product features requirements
- Executes test methods to simulate product use and life for verifying product performance, reliability, and robustness

Requirements

- B.S. in Mechanical Engineering, or equivalent.
- Must have 10+ years of experience in PTCA Balloon Catheter development
- Demonstrates ability to create mechanical designs and make recommendations based on technical inputs from multiple and varied functions (Manufacturing, Quality, Regulatory, etc.)
- Proficient in MS Office, CAD, and mechanical engineering tools (i.e. FEA, DFSS, Matlab, etc.)
- Strong project management experience
- Excellent technical writing and verbal communication in English
- Understanding of Quality System Regulations (QSR) and Six Sigma methodologies experience with Labview, Minitab.

Benefit
401K with company matching
Group Insurance
Paid holidays, sick and vacation times


 

 

 

ID#616 – Senior R&D Engineer – Location: Wilmington, NC – Salary: up to $115K – Product: Orthopedic/Spine Medical Devices

 

Publically held Company, developing minimally invasive surgical instruments.

 

Responsible for leading product development from intial concept through product launch as well as ongoing support for existing product lines.  Collaborates with surgeons and marketing to develop initial design inputs and to optimize prototypes.  Details designs with manufacturing engineers and vendors for manufacturability and market introduction.  Provides technical support for product launch and serves as a resource for surgeons and sales & marketing groups.

 

 

Education: 

o        BS in Mechanical Engineering, Biomedical Engineering or similar discipline with medical device experience (MS a plus)

 

Required Experience: 

o        5+ years of medical device development experience

o        EXPERIENCE DEVELOPING ORTHOPEDIC SURGICAL INSTRUMENTS AND IMPLANTS

o        Experience in Project Management including working with Quality, Regulatory, Manufacturing, Marketing and Suppliers

   Experience with surgeons and animal testing

 

Skills

o        Computer Experience including Word, Excel, PowerPoint, Project required.

o        Effective in conducting mechanical design using 3D CAD (Solidworks preferred)

o        Familiarity with ISO quality systems and FDA QSR

 

Responsibilities

o        Position will involve all phases of product development from initial concept through product launch as well as ongoing support for existing product lines.

o        Work closely with surgeons to develop initial design input and optimize prototypes. 

o        Using 3D CAD system to create models for new designs and product manufacturing prints. 

o        Work with vendors and manufacturing engineers to optimize designs for manufacturability. 

o        Define validation requirements and required mechanical testing. 

o        Provide technical support on products for surgeons, marketing and the sales force.

 

 

 

ID#656 - Senior Principal Mechanical Engineer - Location: Pittsburgh, PA - Salary: up to $100K

 

Develops breakthrough medical devices for respiratory support.  Seek a Senior or Principal Mechanical Engineer to join there Research and Development team and participate in the design, pre-clinical, and clinical testing of there advanced respiratory support devices. You will be reporting to the VP R&D.

 

Responsibilities include:

Lead mechanical engineering efforts (design and analysis) for the development of oxygenators and accessories (includes subassemblies, catheter)

Provide guidance and support the development of the electromechanical driver

Develop Verification and Validation protocols and follow through their completion

Participate in establishing the supply chain and manage suppliers as necessary

Develop documentation as required by the company’s QSR

 

Skills/Requirements:

BS or advanced degree (preferred) in mechanical engineering.

5+ years product development experience (medical device industry preferred).

Hands-on mechanical and electro-mechanical design experience of rotating mechanisms, pumps, polymeric and elastomeric components, and catheters.

Experience in systems level design and analysis.

Preferably possess CAD design skills (Solidworks).

Working knowledge of geometric dimensioning and tolerancing.

Must be able to communicate ideas and information clearly, effectively, and frequently (oral and/or written) within program team and throughout the company

Background in fluid mechanics is preferred

Possess a strong working knowledge of FDA's Quality System Regulation (QSR) and practical application through design control, SOP's, verification, and validation testing

Familiarity with medical device standards and CE mark requirements for international use (including Shock/Vibration, Shipping/Transport, and Environmental requirements)

Experience interfacing with external firms and suppliers (design and contract manufacturers)

 

ID#655 - Principal Engineer - Location: Parsippany, NJ - Salary: up to $110K plus equity

 

MEDICAL DEVICE EXPERIENCE REQUIRED

 

Very early stage startup, experienced successful founders. Solutions for today’s dental implant market. As part of this vision the product development group is driven to ensure that they stay on the cutting edge of implant technology.
As one of the fastest growing implant companies they are seeking a Principal Engineer to join there fast growing product development team. This position will require strong leadership and analytical skills to drive there new products from initial concept to market. This position requires a professional who has experience in successfully conceptualizing, developing, and launching medical products.

RESPONSIBILITIES AND DUTIES
· Lead cross functional project teams to ensure program success and technical rigor
· Interface with external and internal customers to identify and understand new opportunities
· Develop customer and product requirements for new products
· Plan, implement, monitor and deliver designated tasks and deliverables
· Provide expertise in product design and in the engineering discipline
· Lead and guide design for manufacturing approaches for new products
· Provide guidance and lead FMEAs and risk management exercises
· Provide strategy and lead the execution of Design Verification & Validation activities
· Provide hands on support to all facets of product engineering
· Develop and maintain an expertise level in product domain and competitive landscape

QUALIFICATIONS
Minimum BS in Engineering and 5 to 9 years of new product development experience in ORTHOPEDIC OR DENTAL IMPLANTS.

Experience with ISO requirements and GMP guidelines, FDA regulations and medical device design control is required
Experience with a parametric CAD package; SolidWorks preferred

MUST BE PROMOTABLE TO MANAGER ENGINEERING AND MANAGE RAPID GROWTH STARTUP EXPERIENCE DESIRED

 

 

 

ID#649 - Sr. Product Development Engineer/Team Leader – Location: Arizona - Salary: up to $110K plus 20%

 

Partner with physicians, inventors, and corporations to develop medical devices ORTHOPEDIC that improve the standard of patient care. From initial concept to a medical device ready for clinical use

 

Our state of the art facility provides the most advanced tools to support design, prototyping, biomechanical and pre-clinical testing. This growth-oriented Product Development Engineer position will be responsible for all technical aspects of developing medical devices from concept to market success, including

Supervision of Jr Engineer

Strong, hands-on involvement with all phases of medical device development

Conceptualization and primarily mechanical design of medical device procedures, instruments, and implants using fundamental engineering knowledge and principles

Solid modeling via Solidworks of design concepts and creation of design drawings using ASME Y14.5, ISO, and GD&T principles

Creation of development documentation consistent with FDA CFR 820.30, such as product specifications, risk analyses, verification / validation reports, etc.

Fabrication of prototypes in conjunction with the internal prototype shop and outside suppliers

Designing, executing, and analyzing experiments, verification tests, and validation tests using statistical techniques

Transition of new products with production suppliers

Travel as needed for development activities (~10-25%)

Requirements

Bachelor’s degree in Mechanical or Biomedical Engineering – Master’s degree preferred

5+ years experience in design and engineering capacity – Previous Medical Device experience

Strong mechanical engineering, design, and analysis skills

Good verbal and written communication skills

Working knowledge of CAD (Solidworks) and GD&T

 

Company offers a competitive total compensation package including medical, dental and vision, 401-k with employer match and immediate vesting, and an annual incentive bonus program plus relocation.

 

ID#647 – Senior Design Engineer – Location: Austin, TX – Salary: up to $95K – Product: Interventional Endoscopy

  

 This individual will be responsible for bringing a product from concept through design to production. The Senior Design Engineer will interface with cross-functional teams, clinical advisors and vendors for evaluation of new products as well as address design issues/ maintenance of existing ones. This position will take product/process concepts and prepare layouts, tolerance analysis, models and detailing of flexible instruments utilizing Solid Works. Successful candidates must have the ability to multi-task and work effectively under deadlines and timeframes. Experience working in the medical device manufacturing industry is required.

Specialized Knowledge and Skills:
•  Bachelors degree in Engineering, Mechanical preferred.
•  CAD modeling and Drafting Training; Solid Works preferred.
•  Innovative problem solver with ability to work independently and in a team environment.
•  Knowledge & understanding of medical regulations & their impact on business, ISO (International Organization for Standardization) & GMP (Good Manufacturing Practices).
•  Enjoys a work environment with a sense of urgency and personal ownership to meet company timelines and objectives
•  Excellent written and oral communication skills.

 

 

 

ID#626 - Senior Project Engineer – Location: Parsippany, NJ  - Salary: $85K to $120K           

Relevant Work Experience:      5+ to 7 Years

Unique opportunity for an experienced DEVICE DESIGN ENGINEER to work with top surgeons and a leading institution on the development of a breakthrough arthroplasty system. The company is building a team around an existing concept backed by significant biomechanical research and an international team of physicians. The current search is for a technical project leader to design and develop the product.

Candidates must have medical device design experience (orthopedics, total joints a plus), must be proficient in SolidWorks and must have excellent design, communication and project management skills. Candidates must have experience bringing products to market from concept through transfer and must be experienced and familiar with manufacturing processes (precision machining, metalworking)

This is a well funded start-up company presenting the opportunity to work on this top priority project and for career growth in line with the growth and success of the company.

MUST HAVE MEDICAL DEVICE INDUSTRY EXPERIENCE

 

 

 

 

 

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MANUFACTURING ENGINEERING

 

 

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QUALITY ENGINEERING

 

ID#664 - Quality Engineer - Location: Clearwater, FL - Salary: up to $80K - Product: Electrosurgical generators

 

Report directly to the Quality Manager. Responsibilities will include, but are not limited to:

 

·      Investigate manufacturing non-conformances through the Corrective and Preventative Action procedure, determine root cause on non-conformances, and recommend changes or corrections.

·      Write and perform protocols for validation activities identified through Quality Plans and Failure Mode and Effects Analysis protocols. Analyze/evaluate validation data and draw conclusions based on the evaluation.

·      Develop test procedures, test proposed components for product improvement/substitution.

·      Other duties as assigned from time to time.

·      Maintain all documentation according to policies and procedures

·      Assist the Quality Manager pertaining to any issues which may arise.

 

Requirements

 

The ideal candidates will be familiar with the US FDA Quality System Regulation and have experience working within the requirements of an ISO Quality System; have the ability to work independently, have experience on capital equipment devices, have the ability to investigate and evaluate quality trends; have a bachelors degree in electronics engineering with a minimum of 5 years experience in a manufacturing environment. Working knowledge of risk analysis methods (FMEA, FTA) and design verification is also desirable.

 

 

 

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ENGINEERING MANAGEMENT

 

 

ID#663 - Director of Engineering – Location: Sheboygan, WI – Salary: up to $110K – Product: Orthodontics

Seeking a dynamic individual to fill the role of Director of Engineering. If you are looking for a challenging opportunity and a rewarding career in an exciting and growing industry, join our winning team.

Reporting to the President, the Director of Engineering is responsible for assisting the organization to develop and achieve short and long-term objectives by providing effective leadership of engineering resources, through successful execution of an engineering functional strategy.  This position will be responsible for providing leadership and management of all engineering functions related to engineering personnel, product design, plant operating performance, system and process design and reliability, and the cost and quality for our manufactured products.  

Leadership 

·       Participate in overall business and company planning as part of the senior management team.

·       Keep the Management Team informed of important engineering and manufacturing developments, potential problems, and related information necessary for effective management

·       Update management on product development projects to allow teams to focus on project execution and to assure completion on time and within budget.

·       Coordinate/communicate and plan activities with management, QC, and manufacturing, as appropriate, to ensure a coordinated work effort.

·       Develop an organizational structure and climate that will optimize effectiveness throughout engineering and our tool room.  Ensure that all positions are staffed with properly qualified and motivated employees.

·       Provide Engineering Leadership and Management to ensure that the department and staff are fully capable of meeting the organizational needs.

·       Conduct performance appraisals and identify/communicate plans for individual employee improvement.

 Processes 

·       Act as leader to provide value through proficiency in structured problem solving techniques and in project management and control.

·       Strategically plan, provide leadership and manage manufacturing process machinery requirements, layout, and capacity planning related to existing products as well as new products introduced to the market

·       Assure projects are properly managed, planned and monitored, that status is well communicated, and that results meet the organizational expectations.

·       Ensure engineering activities meet continuous improvement initiatives both from a strategic and tactical perspective including lead time reduction, quality improvement, and cost reduction.

·       Execute to achieve short and long range objectives for Engineering. Identify and resolve internal and external issues that affect the ability of the engineering department to be successful.  

Products 

·       Provide company leadership for the continuous flow of product innovation and improvement, including the application of new technologies, within the framework of the company’s long-term strategy.

·       Provide leadership and manage product engineering design and material selection

·       Provide department leadership to assure that immediate and short-term product issues are resolved through rigorous & disciplined sustaining engineering systems, tools and focus.

·       In conjunction with QC, assure that applicable approval body/regulatory (FDA, ISO) testing and acceptance are accomplished to ensure the organization’s right to ship and in support of project schedule requirements.

Requirements

Successful candidates will possess the following qualifications:  

·       The successful candidate will possess a Bachelor’s degree in Engineering or Applied Science. Master’s degree desirable.

·       Minimum of 5+ years of experience in engineering management and a total of 10+ years experience related to Engineering within the medical device field preferred.

·       Knowledge of Six Sigma and lean manufacturing techniques is desirable.

·       Experience with FDA and ISO regulations.

·       Operations and financial mind-set, understands the fundamentals of a customer focused manufacturing operation and basic business principles.

·       Strong tactical skills, experience in managing processes and creating accountability to process adherence. Able to drive the processes home while maintaining a balance between the objectives and customer need.

·       Competent people manager with the ability to understand not only technical aspects of role but also knows how to lead and motivate professionals.

·       Effective communicator, written and oral, with others at all organizational levels. Knows when to communicate, what to communicate and the right level of information to communicate.

·       Team player, experience in structured team building.

·       Working knowledge of Solid Edge and CadKey software, as well as efficient user of Microsoft office products

·       Willingness to be a “hands on" leader.

 

 

 

 

ID#631 - Principal Electrical Engineer/Manager – Location: San Diego, CA – Salary: up to $135K plus equity – Product: implantable medical sensors

 

Develop system architecture and circuit designs for unique implantable medical monitoring devices.  This senior electrical engineering position will lead an in-house engineering team and will be responsible for electronic system design and qualification, including management of mixed-signal ASIC-related development projects.  Responsibilities include:

Providing technical expertise in the area of low-power medical device circuit design

Managing embedded system architecture and low-level design development, including software

Leading an engineering team and coordinating electrical engineering development activities with other engineering groups within the company

Ensuring that development efforts are conducted in accordance with FDA Quality System Regulations

Developing performance, reliability, and cost criteria

Verifying that designs and components meet required needs

Selecting suppliers and managing supplier performance

Developing high-quality engineering documentation in support of product development

Company Culture

Company provides a rewarding and stimulating environment where creative, motivated professionals are working to develop life-changing products.  Company offers competitive salaries and benefits in an atmosphere where creativity is valued. 

Requirements

Minimum 5 years product development experience in the medical device industry

Bachelor’s degree in Electrical Engineering (BSEE)

Excellent written, verbal, and presentation skills

Practical working knowledge of embedded systems, analog/digital circuit design and analysis, and manufacturability for high-reliability medical device products; experience with RF circuits and wireless data communication systems is desirable

Track record of success in engineering projects including execution of milestone-driven projects in a team environment

High degree of computer literacy

Software validation experience desirable

Experience with analog / mixed-signal ASIC development a strong plus

 MUST HAVE MEDICAL DEVICE INDUSTRY EXPERIENCE

 

 

 

  

ELECTRICAL ENGINEERING

 

 

 

 

 

 

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