Job Title: Senior Design Engineer (direct hire $100k-$120k)
Location: Trumbull, CT
The Senior Design Engineer is the primary technical resource on a product development or sustaining engineering team and performs her or his duties with minimal supervision. The position is responsible for ensuring that project objectives are met accurately and on time. Responsibilities include design, development, testing, troubleshooting, technical documentation, transfer to manufacturing and support of manufacturing, and conformance to all relevant regulations.
- Designs, prototypes, tests, and develops components, sub-assemblies and systems of up to high complexity
- Analyzes designs using FEA, tolerance stack analysis, and any other appropriate tools.
- Creates test protocols, runs experiments and writes test reports.
- Completes product documentation of moderate to high complexity.
- Creates, revises and documents drawings and specifications.
- Analyzes moderate to high complexity engineering problems, defines problem, recommends and implements solutions.
- May lead projects of limited complexity.
- Advanced proficiency in design, drawing, and CAD skills, such as SolidWorks.
- Proficient with GD&T, Finite Element Analysis, free body diagrams, FMEA, engineering drawings, and documentation.
- Proficient with designing and testing using rapid prototyping techniques.
- Experience with manufacturing techniques common to medical devices - injection molding, machining, stamping, casting, MIM, etc.
- Proficient with inventing, innovating and launching products.
- Proficient with analysis and problem solving.
- Experience with lab testing and fabrication equipment (force gauges & test stands w/data acquisition, 3d printers, etc.)
- Familiarity interacting with all functions within a business.
- Ability to utilize common office and web-based software (email, spreadsheets, word processing, presentations) 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, and 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.
- 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 with 8+ years industry experience, PhD with 3+ years industry experience.
- Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) and EU MDD/MDR requirements.
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.