A Technical Recruiting Organization Serving Medical Product Companies

Available Opportunities

 


Search our list of currently available jobs in General Engineer Management and Supervision, Packaging Engineering, Mechanical Product Design Management, Software Engineering, Manufacturing, or Scientific Areas. NO SALES POSITIONS


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#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#650 - Senior Project Engineer – Location: Ohio – Salary: up to $75K 


SUMMARY
Responsible for project management of new and legacy product. Will act as a single point of contact for all customer communication. Responsible for coordination of estimating, contract review, preproduction planning and post production review. Must be capable of performing design for manufacturability analysis with product development engineers. Manages past due, on time delivery, customer acceptance and other customer specific metrics. Responsible for coordinating continuous improvement activity as it pertains to assigned customers. Interfaces closely with Manufacturing, Applications Engineering, Production Planning, Purchasing and Quality Departments to ensure total customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsible to lead a team that consists of engineering and manufacturing personnel to develop manufacturing processes that meet customer/internal standards and specifications while assuring profitability.

Responsible for identifying continuous improvement opportunities using Six Sigma techniques. Authorized to initiate changes to processes for these improvements.

Responsible to head, steer and recruit members of Pre and Post Production teams. Authorized to determine final outcomes.

Responsible and authorized to generate and disposition CAR/PAR and NCMRs. Responsible to develop WIs and IPs and to provide initial training of these to entire team. Responsible for generating BOMs and Routers. Responsible for generating Engineering Document Changes.

Education Requirements
Bachelor's degree (B. S.) from four-year college or university with 3 to 5 years experience, or equivalent combination of education and experience.


**Salary requirements must be included**

Benefits: Medical Insurance, Life Insurance, Dental Insurance, Paid Vacation, Paid Sick Days, Paid Holidays, Long Term Disability, 401K/403b Plan, Educational Assistance

Screening Requirements: Drug Screen, Criminal Background Check, Physical Exam

 

 

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

 

ID#654 – Manufacturing Engineer – Location: Ohio - Salary: to $80K – Product: Orthopedic

 

Through effective process development, the Manufacturing Engineer works cross-functionally with Programming Manufacturing, Quality, and Customer Focus to provide robust manufacturing requirements. In addition, the Manufacturing Engineer enhances current processes.

Key Roles and Responsibilities:

Technical: New product development, layout the manufacturing process incorporating all aspects of product design criteria.

Assist with Design for Manufacturability (DFM) analysis on new and existing orders.

Identify, assess, and participate in continuous improvement opportunities using proven technical engineering tools and programs.

Improving existing operations, incorporating new methods and processes.

New equipment purchase and installation.

Investigating operational problems affecting production and dealing with them in a systematic, methodical manner.

Preparing manufacturing documentation required for product manufacture.

Co-coordinating projects.

Providing manufacturing data.

Running meetings with other team members.

Identifying ways to reduce production costs.

Working with engineering and other departments to produce cost estimates for new designs.

Understanding and analyzing graphs and statistics and other complex information.

Giving presentations to engineers and colleagues in other departments.

Liaising with suppliers and customers.

Workings with regulatory bodies to ensure safety, environmental and design standards are met.

Leadership:

Effectively coordinate resources within Eng to accommodate production schedules, manage project plans and ensure appropriate communication.

Lead and/or participate in pre-production planning and post-production assessment processes.

Communication:

Maintain effective communication with internal stakeholders regarding status, timing and production or manufacturing issues impacting the project.

Communicate with others throughout the organization to provide regular updates

Required Knowledge, Skills, and Abilities

Bachelor’s degree in Mechanical, Manufacturing or other related Engineering disciplines. Prior experience with orthopedic medical device manufacturing preferred.

Strong knowledge of CNC milling/turning and secondary operations such as but not limited to burring, blasting and passivation

Disciplined in cad software, use of Solidworks or Unigraphics preferred. 

Working knowledge of Quality analytics tools including but not limited to SPC, FMEA, PFMEA preferred.

Strong working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint and Project.

Ability to read and interpret complex blueprints.

Working knowledge of GD&T preferred.

 

 

 

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QUALITY ENGINEERING

 

 

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ENGINEERING MANAGEMENT

 

ID#659 - CEO - Virtual Company, Telecommute - Product: Orthopedic Implant - Salary: to $200K plus equity

The candidate should possess extensive knowledge of the business processes involved in the development, commercialization and sale of implantable medical devices, especially in EC markets, and have a history of successfully financing early stage companies.

Ability to raise initial $1 million in seed money to finance large animal clinical trials and then secure "A" round capital of $5 million to finance human trials in Europe.

Responsible for complete product development cycle, including negotiating license agreements, marketing, sales, business development and qualifying and developing vendors.

Qualify and supervise outside consultants.

Develop commercialization, clinical strategy and distribution partners and sales.

Strong understanding of implants, orthopedic, knee, biomaterials and minimally invasive surgery. Knowledge of manufacturing processes for hydrogel, implantables.

Will build and manage sales and distribution network throughout the EC.

Require BS Science related, Marketing, MBA degrees

Reports to Board of Director

Record of successful start up medical product commercialization

 

 

 

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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