About the job

ONWARD Medical is hiring a Sr Mechanical Engineer as part of the product development team that designs, develops, and implements medical devices for electrical spinal cord stimulation. Within the multi-disciplinary team, you will be responsible for the mechanical engineering of implantable and/or external spinal cord stimulation devices, body worn devices, the design of mechanical tests, test fixtures and interface with manufacturing.

Responsibilities

• Drive the design, development, manufacturing, and testing of new generations and continuous improvements of our neurostimulators, body-worn devices, and other accessories through hands-on development work and leadership of external development and manufacturing partners.

• Act as a subject matter expert for injection moulding design and process development for re-engineering prototype designs and pursing industrial designs early in the development cycle.

• Collaborate on Agile teams cross-functionally with Product Management, Program Management, System Architect/Engineering, Electrical Engineering, Clinical, Regulatory, Quality, Operations, Human Factors Engineering, and Marketing.

• Perform functional analysis, create feasibility concepts, and mechanical designs that meet requirements.

• Lead mechanical responsibilities for risk management (DFMEA) and Design Input Requirements for assigned products and/or subassemblies.

• Perform structural analysis, detailed tolerance stack and close clearance analysis.

• Employs DRM (Design for Reliability and Manufacturing) tool sets, to include concept engineering, modelling and analysis, sensitivity studies, stress analysis, DFMA (Design for Manufacturing and Assembly), DFT (Design for Test) and other relevant skills.

• Work on manufacturing process development, including documentation (DMR), process feasability (CPK/PPK), process qualification (IQ/OQ/PQ), incoming inspections, and PFMEA.

• Work closely with Quality and Regulatory, e.g., on supplier audits, CAPAs follow up, Nonconforming materials, etc.