We are currently seeking a Senior Mechanical Project Engineer (R&D) to work for a client in Trumbull, CT on a direct hire basis. Mechanical design experience needed within medical devices. Candidates need to have tenure in positions throughout their work history. Candidates with jumpy work history or all contract work will not be considered.
The Senior Mechanical Project Engineer is the primary technical resource on a product development or sustaining engineering team and performs their duties with minimal supervision. The position is responsible for providing technical leadership to the development team that includes design, development, testing, troubleshooting, technical documentation, transfer to manufacturing and conformance to all relevant regulations. The right candidate will be expected and excited to provide mechanical design support to existing and in-development products. Must be comfortable in a fast-paced environment.
- Designs, prototypes, tests and develops components, sub-assemblies, systems and full products of up to moderate complexity.
- Creates test protocols, runs experiments and writes test reports.
- Completes product documentation of moderate to high complexity.
- Analyzes moderate to high complexity engineering problems, defines problem, recommends and implements solutions.
- May lead projects of limited complexity.
- May lead technicians.
- Proficient with mechanical design tools (SolidWorks, AutoCAD), GD&T, Finite Element Analysis, free body diagrams, FMEA, engineering drawings and documentation.
- Experience with designing and testing using rapid prototyping techniques.
- Design, fabrication and testing proficiency with common manufacturing techniques for high-volume, disposable parts - machining, injection molding, stamping, casting, MIM, etc.
- Experience with root cause analysis and corrective/preventive action procedures.
- Proficiency inventing, innovating and launching products.
- Proficiency with analysis and problem solving.
- Proficiency with design of experiments, protocol and model development, testing and documentation.
- Experience with lab testing and fabrication equipment (force gauges & test stands w/data acquisition, 3d printers, etc.)
- Proficiency interacting with all functions within a business.
- Proficiency in clinical and pre-clinical settings.
- Ability to utilize common office and web-based software (email, spreadsheets, word processing, presentations) effectively.
- Ability to present technical materials to non-technical personnel up to 2 levels higher effectively.
- Knowledgeable of and work within FDA, MDD, ISO, CSI and other relevant standards.
- Work is expected to contribute to the launch of new products, defining and solving field and manufacturing related problems as a supporting or lead member of a team.
- Work contributes to projects that are critical to the future success of the business.
- Interacts with R&D staff, cross-functional partners (Marketing, Manufacturing, RA, QA, labeling, legal, etc.) on a daily basis.
- Interacts with customers and vendors.
- Will interact with organizational leaders on an infrequent basis.
- Reports to R&D team leader.
- Has launched numerous products in the medical device field of low to moderate complexity.
- Contributed as team member to launch of new products.
- Contributed as team member to sustaining engineering activities.
- Bachelor's Degree in Engineering with 10+ years industry experience, Master's degree in engineering management or business with 8+ years industry experience, PhD with 3+ years industry experience.
- Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements.
- 1st shift
- Direct hire, salary range $120 - 135K
- Health insurance coverage, 401(k) and a defined pension plan, paid time off for vacation, personal, sick and holidays, as well as a wide range of other perks and benefits.
Monroe Staffing Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment and will not be discriminated against based on their race, color, Religion, gender, disability, veteran status, sexual orientation, gender identity, national origin or other protected classification.