Senior Product Engineer- Mechanical

Responsibilities

• Drive troubleshooting, coordinate root-cause analysis for complaints and CAPAs and devise solutions and approaches for solving technical problems (solution gameplan) and overcoming development challenges in an inclusive and collaborative fashion.
• Design and develop and improve components and assemblies using first principles, applied mechanics, fluid and thermodynamics, mechatronics, and mechanisms as well as engineering best practices associated with CAD, GD&T, Modeling, and DFSS.
• Define design inputs (i.e., product requirements), develop design outputs (i.e., product specifications), define technical strategies for an adequate verification and validation approach.
• Drive successful verification and validation testing.
• Ideate, conceptualize, and build concepts and prototypes to aid incubation of new opportunities or down-select wining solutions for new product developments, upgrades, or improvements.
• Create simulation and mathematical models as appropriate to demonstrate functional feasibility of technical solution based on experimental, numerical, statistical, and/or finite-elements tools and techniques.
• Develop test methods and fixtures for products, components, and systems simulation, evaluation, and verification testing.
• Deliver agreed project outcomes on-time and on-budget per project plan.
• Scope, plan, and manage execution of assigned project tasks, workstreams, and deliverables ensuring full alignment with the overall project plan and business objectives.
• Train, mentor, and provide technical directions to junior engineers and team members as appropriate to ensure that desirable business outcomes are achieved.
• Manage execution and relationships with external partners, engineering consulting firms and vendors.

Qualifications

• Expertise in CAD modeling (SolidWorks), mechanical design and creation of engineering drawings including GD&T – required.
• Medical device development experience with thorough understanding of design control guidelines including verification and validation methods – required.
• Proficiency with engineering first principles and analytical methods including structural and fluid mechanics – required.
• Advance understanding of Design for Manufacturing (DFM) – required.
• Understanding of statistical methods including design of experiments – required.
• Ability to plan activities and lead technical teams or work independently with minimal direction – required.
• Hands-on craft skills and experience with building, fixing, servicing and/or fabricating concepts, fixtures, prototypes or similar – required.
• Experience with translating customer to product requirements, conducting harm-based risk analysis and defining acceptance criteria – preferred.
• Experience with electro-mechanical, robotic, or digital systems – preferred.
• Experience with FEA and/or CFD mathematical modeling – preferred.
• Proficiency with Design for Six Sigma (DFSS) – preferred.
• Experience with identifying latent user needs and front-end of innovation process – preferred.
• Significant experience in a medical device product development environment required.
• Mechanical or biomedical engineering experience or combination with other related fields in medical device or related industries is required.
• Cross-disciplinary education and/or experience such as mechatronic, electro-mechanical, mechanical-materials, electrical-biomedical, etc is highly desirable.
• Minimum BS w/ 5+ or preferably MS w/ 3+ years of combined education and experience in development of medical devices or related fields.