You will create product designs and will author design rationale to document basis of all design features.
You will prepare and review information for invention disclosures and patents.
You will work with cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation.
You will create product production specifications for manufacturability (process capability) and inspection
You will identify and document critical to quality product features, associated user risks and the design itself for quality control inspection plans
You will evaluate, verify and validate product designs relative to design requirements aligned to global regulatory requirements (e.g. completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations).
You will support the Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities.
You will develop new test methods and/or predictive modeling as required to evaluate new products, and complete test method validation.
You will support the Regulatory Affairs team (e.g. creation of new product regulatory submission documentation, etc.) and the Clinical Affairs team (e.g. creation of clinical study plans and protocols).
What Makes You Stand Out
Ideally you have parametric CAD modeling experience (SolidWorks is preferred).
Ideally you have experience with finite element analysis predictive modeling.
Ideally you have demonstrated product design and development execution with a multi-disciplinary project team from user need identification/concept ideation through commercialization.
You have demonstrated working knowledge of statistics with application to sample size determination, design of experiments and null hypothesis testing (preferably Minitab experience).
You are proficient with Ansys Software.
Ideally you have Six Sigma experience.
Your Background
Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience required.
B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering highly preferred.
5 to 7 years of engineering work experience highly preferred.
You have demonstrated understanding of various manufacturing processes (including subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development.
You have strong understanding of FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge.
You have working knowledge of ASME GD&T standards with application to product design.
Travel Expectations
Up to 5% travel might be required.
Expected compensation for the role is $119,000 - 149,000 base per year plus performance bonuses.
EOE
