Senior Mechanical Engineer (Onsite)

Position Summary 

We are looking for a self-motivated Senior Mechanical Engineer to join the Lifecycle/Sustaining Engineering team responsible for sustaining and implementing breakthrough improvements to on-market products. Additionally, this position will be highly involved in leading root cause analysis of product failures and customer complaints to identify appropriate improvements. This position will be integral in supporting and/or leading project teams to improve quality, reduce costs, and improve supply chain stability.  The person in this position will also be required to design, execute and report on engineering tests, for both feasibility and product verification.  The candidate must have a strong engineering background with the ability to quickly understand electro-mechanical assemblies and a track record of delivering results on cross functional development and project teams.   

 The Ideal candidate will have significant experience with precision component manufacturing for high-volume assembled devices including precision plastics, metal stampings, screw manufacturing, and packaging design. The ideal candidate additionally has experience working with suppliers of custom precision components for use in medical devices, automotive, or another highly regulated industry. 

Responsibilities 

• Design iterations of existing products to improve quality, service, and cost 

• Design and set up feasibility tests to evaluate concepts, new materials and components 

• Support/lead cross functional teams as a mechanical engineering representative and/or project leader depending on project scope 

• Develop/execute engineering project plans to burn down risks and optimize resource utilization 

• Lead and support root cause analysis for product failures and other issues 

• Author product qualifications test and report results 

• Design test fixtures for product qualification using CAD and/or other technologies 

• Interface with external suppliers, consultants, experts, as needed 

• Review documents and engineering change orders and maintain documentation control prior to release. 

• Travel overnight(s) as necessary both domestically and internationally to support project goals. 

• Liaison cross functionally with stakeholders to drive alignment with project goals. 

Education and Experience 

Minimum Requirements: 

• Bachelor of Science in Mechanical Engineering or related field. 

• Minimum of 5 years’ work experience, preferably in device design and development in a regulated industry. 

Preferred Skills and Competencies: 

• Master’s degree a plus. 

• Experience with design verification and validation and engineering study design 

• Experience with component design and material selection 

• Experience with organized root cause analysis (5 whys, is/is not, Ishikawa, etc) 

• Experience with formal Risk Management tools including Preliminary Hazard Analysis (PHA), System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA). 

• Experience with projects involving domestic and international regulatory submissions. 

• Demonstrated excellent project team skills as part of a cross-functional team that includes development/procurement/manufacturing/regulatory and quality experts. 

• Cross functional team leadership experience a plus. 

• Experience leading engineering projects 

• Experience with continuous improvement methods and toolsets such as Six Sigma, Kaizen, CTQ and Critical Parameter Management. Six Sigma Green Belt or Black Belt certification is a plus. 

• Experience with CAPA is a plus 

• Experience in a project leadership role 

• Working knowledge of medical device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). 

• Statistical Analysis (t-test, tolerance interval, confidence interval, ANOVA). Familiar with Minitab and/or JMP. 

• Working knowledge of Computer Aided Design & Finite Element Analysis. Advanced knowledge a plus 

• Formalized problem solving (Cause and Effect, A3, 5 Whys8Ds, DMAIC, PDCA). 

• Ability to learn and adapt quickly in a fast-paced dynamic environment 

• Ability to identify, organize, and judge priorities and make recommendations to management. 

• Basic project management skills (advanced skills a plus) 

• Ability to communicate and collaborate within a cross functional project team. 

• Ability to present and communi