Peterborough, United States
about 2 years ago
Sustaining Product Engineer Job Description
The Sustaining Product Engineer is the primary technical contributor and interface for all the company’s products and accessories in production and transitioning to production. The candidate has a range of engineering skills needed to understand all aspects of product functionality, investigate and identify the root cause of field failures, manage and implement design changes from inception to release, recommend and/or assess production process changes and identify and recommend cost reducing scenarios. The Sustaining Product Engineer is part of the broader Engineering team and works closely with the product development engineers, Operations and Quality and Regulatory teams while interfacing to external contract manufacturers.
- Root Cause Analysis: Work directly or in conjunction with the Contract Manufacturer and the Quality department to evaluate product performance against product requirements and determine the root cause of field reported failures. Use existing test methods and equipment and/or generating new tests if required.
- Design and Process Change: Evaluate and approve proposed design changes and process changes sourced from the contract manufacturer. Initiate design changes stemming from field issues and cost reduction initiatives.
- Documentation: Own the execution of the engineering team’s workflow of the DCO process from start to finish, including maintaining and modifying the product BOM, product labelling, component CAD drawings, product assembly drawings and packaging drawings.
- Manufacturing Process Development and Implementation: Support the company’s Operations team for instances where internal manufacturing processes are introduced.
- Design Transfer: Work with the R&D team to transition designs into volume production, typically with a contract manufacturer.
- Manufacturing Partner Development: Work with Operations, Quality and Regulatory departments to locate and qualify new manufacturing partners as the product line grows.
Compulsory Experience and Qualifications
- Minimum of a bachelor’s degree in Engineering, preferably Mechanical engineering background with experience in cross-disciplinary work that includes electronics and software
- Medical device manufacturing experience strongly desired. Minimum of 3 years sustaining a product that is actively in production
- Minimum of 2 years of experience with SolidWorks
- Design transfer of a product to volume manufacturing
- Prior employment as a manufacturing engineer
Medical product development and/or production