Senior R&d Engineer
About The Position
Design and develop new devices or elements of new devices with the intent of commercialization according to Quality System Requirements. Participate as a technical lead on multiple cross-functional development teams managing projects from concept through commercialization. Design, assemble, and evaluate prototype devices/assemblies to assess technical feasibility. Support translation of user and patient needs into verified and validated devices by creating and refining design requirements, specifications, and test methods. Develop robust test methods and design test fixtures. Communicate deliverable status cross-functionally to facilitate product development.
Requirements
- 5+ years of experience in medical device development.
- Strong understanding of ISO certifications.
- Experience in product development from concept to commercialization.
- Proficiency in Solidworks for CAD design.
- Knowledge of injection molding, extrusion processes, fixture and tooling design.
- Project management skills and understanding of design control methodology.
- Familiarity with quality systems and medical device regulations.
Nice To Haves
- Bachelor's Degree in Engineering or a related technical field.
- Experience with catheter materials, processes, and design.
- Knowledge of clinical applications and ability to translate requirements into detailed specifications.
- Experience in taking products through development to launch.
Responsibilities
- Serve as technical lead for projects/products, identifying and implementing solutions to complex problems.
- Interface with physicians and other medical personnel professionally.
- Author protocols and reports, including engineering studies using basic statistical methods.
- Communicate with outside suppliers for component and equipment sourcing and refinement.
- Assist or own verification and validation activities through regulatory clearance and design transfer, including building finished devices for verification/validation.
- Contribute to the design and development of product line extensions and improvements.
- Mentor peers and junior engineers to advance R&D technical abilities and core competencies.
Benefits
- Employer subsidized health insurance for employees
- Employer paid dental insurance
- Employer HSA contribution
- 401k plan with a company match
- 9 paid holidays (including your birthday!) + PTO and Personal days
- Gym membership subsidy
- Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Administrative and Support Services
Number of Employees
1,001-5,000 employees
