R&D Product Development Engineer

Job Title – R&D Product Development Engineer

Location – Andover, MA

Duration – 3+ months

Total Hours/week - 40.00
Shift/Hours: 1st Shift ( 8-9am to 4-5pm) / 40hrs

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1b’s

R&D Lab
On-Site 100%

Key responsibilities will include:
- Define, plan and lead activities, including test method & measurement system design/development and validation, fixture design and testing optimization in support of Design Verification
- Write detailed test procedures that evaluate product sub-systems and systems against documented requirements
- Execute critical product functional testing and conduct statistical analysis of test results
- Author verification or validation reports upon execution of respective tests
- Participate in the planning and execution of technical project work involving the application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and to propose design or test method improvements
- Create and document novel test methodologies and make recommendations for product/design changes
- Ensure compliance with Client quality policies, procedures and practices as well as with all local, state, federal and Client safety regulations, policies and procedures.
Education and experience required:
- Bachelor’s degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering with mechanical emphasis, Electrical Engineering or related field
- Proficiency in the use of SolidWorks CAD, and experience with designing complex mechanical and/or electromechanical components or assemblies using SolidWorks
- Proficiency in basic statistical techniques for Engineering, including calculation of Means, Standard Deviations, use of Hypothesis Testing, etc.
- Familiarity with using Minitab for statistical analysis of product test data
- Ability to work independently and juggle multiple priorities
- Strong project management experience working with multiple partners concurrently
Education and experience preferred:
- 2 or more years of post-baccalaureate professional experience leading or supporting product development projects
- Experience with planning and executing appropriate Measurement System Analysis; including Gage R&R, to establish test method suitability
- Experience with injection molded plastics and high-volume disposables
- Knowledge of intermediate or advanced statistical techniques; including familiarity with analysis of variance (ANOVA), Gage Repeatability and Reproducibility (Gage R&R) and design of experiment (DOE) methodologies highly desired
- Proficiency in executing scripts and performing data analysis with MATLAB
- Solid understanding of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845