Principal / Staff Mechanical Engineer - medical device

InnoTECH Staffing is looking to hire a Principal / Staff Mechanical Engineer for an exciting medical device company in the Somerville, MA area.
This reports to the Director, R&D. This is an onsite role in the lab in Somerville, MA.

The Staff Mechanical Engineer will develop, test, and deploy the systems for new devices to expand the company's portfolio of products from concept to launch. The ideal candidate is passionate about patient care, has excellent problem-solving skills, experience developing medical device designs, is knowledgeable about FDA-regulated design and development processes, is comfortable in a fast-paced and rapidly growing business, and has excellent communication skills.

Responsibilities:

• This role will be tasked with new mechanical development of RPM products. This includes all phases of medical device development.
• Own system/subsystem/component level design and their project management process including timeline/resource management/manufacturing plan/tests/design reviews.
• Apply knowledge of engineering principles to design, develop, test and analyze all aspects of RPM devices.
• Establish and apply design guidelines for design for manufacturability, design for test, and design for quality/reliability.
• Support comprehensive medical device verification and validation strategies at the subsystem and system level.
• Collaborate with cross functional team members on proving design feasibility, functionality, and performance by conducting benchtop tests, functional testing, and user studies to ensure the mechanical design meets system requirements, user needs, basic safety, and essential performance requirements.
• Support the development of manufacturing test fixtures and documentation.
• Support the documentation for all phases of the design including requirements, specifications, risk analysis, plans, reviews, test procedures, test reports, and design for manufacturing etc. in accordance with the QMS.
• Assist in sustaining and improving the reliability of existing products as needed.
• Mentor junior engineers and lead design reviews.

Qualifications:

• 10+ years’ experience with bachelor’s degree OR 8+ years’ experience with a master’s degree in mechanical engineering or related field
• Specialized in medical device engineering, versed in 21 CFR 820 design regulations, IEC-60601, ISO 13495 & ISO 14971 standards.
• Demonstrated experience in Medical Device Development process through a minimum of 2 medical product launches and hands on experience in requirement management, risk management, human-centric design, planning for design verification and validation, human factor study, IQ/OQ/PQ practices etc.
• Ability to produce, review, and understand engineering drawings, GD&T and tolerance analysis expertise required.
• Strong understanding of DFM, DFMA, DFSS and its various tools.
• Strong understanding of material selection for various prototyping /manufacturing techniques including 3D printing, metal manufacturing, thermoforming, vacuum forming, adhesive methods etc.
• Design for plastic injection molding experience is required.
• Experience in electromechanical and product packaging design is a plus
• Experience in design including various physiological sensors such as load cells, ECGs, PPGs, thermistors, cameras etc. is desired.
• Strong CAD experience with advanced surface modeling skills is required. Solidworks Certified Professional is preferred.
• Experience in FEA for Static/Thermal component and system level analysis is required. Proficient in CAA tools using SolidWorks Simulation (preferred), ANSYS or similar for static/dynamic/thermal analysis.
• Familiarity with C, C++, Python, Matlab, Minitab for DFSS tools, Arduino

Compensation and Benefits:

Annual bonus opportunity

Stock Option Grant

Flexible Paid Time Off

16 weeks of paid parental leave.

Annual Tuition and Fitness reimbursements

Home office Stipend after 90 days of employment

Cell Phone Stipend with installation of MDM software

Competitive Medical, Dental, and Vision plans – company covers 80% of premiums.

Health Savings Account option

Health Reimbursement Account when covered under a company sponsored health plan

Employee Assistance Program - Free, confidential advice for team members who need help with stress, anxiety, financial planning, and legal issues

401k; match up to 4% with no vesting schedule

Life Insurance - Company pays 100% of the cost of Basic Life & Personal Accident Insurance.

Disability insurance – Company pays 100% of the cost of Short-Term and Long-Term Disability Insurance.

Additional life insurance, critical illness, and accident coverage are available.