Sr. Mechanical Engineer

Responsibilities ● Design & develop products from concept to mass production ● Design & prototype test fixtures and test equipment for R&D and mass production ● Create and manage product/ project documentation throughout the product life cycle, in accordance with the company’s ISO13485 QMS including: ○ Product development plans (PDP) ○ Design inputs, product requirements, and design outputs ○ Design Verification & Design Validation Plans as well as supporting documents, reports, and matrices. ○ Failure mode effect analysis (FMEA) ● Calculate (excel/ hand calcs) important design criteria, such as forces, stress, deflection, wear, etc and create FEA models/ simulations when necessary ● 3D CAD design for manufacturing, spanning a variety of processes, including milling, turning, and injection molding. ● Create engineering drawings with GD&T best practices ● Plan and manage design reviews and releases per the project schedule ● Create and approve ECRs (engineering change requests) ● Analyze manufacturing data for assigned projects to ensure requirements and quality metrics are met. ● Manufacturing process & material research and development ● CAM and operate CNC to produce prototypes and test fixtures (training will be provided) Qualifications ● 5+ years of relevant experience in medical device design/ manufacturing ● Bachelor’s degree in Mechanical Engineering or related fields ● Lead engineer on product(s) that made it to series production ● Proficiency in 3D CAD design, FEA, and 2D drafting/ drawings ● Experience designing parts for a variety of machining processes ● Experience with a broad range of finishing processes ● Experience with medical device design & manufacturing documentation throughout the product development process ● Experience with ISO13485 quality system ● Self motivated and capable of driving and leading projects ● Good planning and time management skills ● Comfortable with and capable of solving very complex and ambiguous problems and managing multiple projects simultaneously Nice to Have ● Siemens NX Experience ● CAM & CNC experience Job Type: Full-time Pay: $90,000.00 - $120,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance Schedule: 10 hour shift 8 hour shift Work Location: In person