Senior R&D Mechanical Design Engineer
About the Role:
We are seeking an experienced Senior R&D Mechanical Design Engineer to lead product development activities for customer projects. The successful candidate will ensure that customer requirements are defined, resolved into solutions, and translated into product specifications for transfer to production.
Key Responsibilities:
* Engineering development of user-focused product solutions that are optimized for manufacture.
* Liaise with customers to complete design and technical reviews.
* Work with the PM to define, plan, track, and report on Product Development projects.
* Lead development of project proposals outlining cost, schedule, risk, etc.
* Collaborate with the Quality team to evaluate product non-conformances and recommend design modifications if necessary.
Requirements:
The ideal candidate will have a minimum of 6 years' experience in product development for medical devices, ideally in highly regulated Class III devices. A demonstrated understanding of various types of manufacturing, mechanisms, materials, tolerance-analysis, and design-for-manufacturing is required.
A strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively through strong technical and/or project leadership experience is required. Excellent problem-solving, decision-making, and root cause analysis skills are also essential.
Preferred Skills and Qualifications:
* Highly experienced in product specification design; translation of design inputs to engineering outputs, tolerance stack up analysis, as well as product testing.
* Experience of working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
* Knowledge of medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO quality requirements.
* Experience designing for manufacturability particularly for plastics, and experience with related supplier management.
* Proficiency in 3D CAD (e.g. Solidworks) and MS Office Suite.
Contact Information:
Please see our website for more details.