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A Technical Recruiting Organization Serving Medical Product Companies |
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Available Opportunities |
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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 . ID#658 - Research
and Product Development Engineer – Location: Medical catheter manufacturer located in the 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: 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. Responsibilities Requirements - B.S. in Mechanical Engineering, or equivalent. ID#616 – Senior
R&D Engineer – Location: 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: 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: 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. Experience with ISO requirements and GMP guidelines, FDA
regulations and medical device design control is required ID#650 - Senior
Project Engineer – Location:
ID#649 - Sr.
Product Development Engineer/Team Leader – Location: 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: 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. ID#626
- Senior Project Engineer – Location: 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 ID#654 –
Manufacturing Engineer – Location: 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. 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 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: 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 |
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