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Senior Research And Development Engineer
2 months ago
W2 ONLY (unable to work C2C or sponsor visa)
Principal R&D Engineer (12-month contract // Plymouth, MN):
Hybrid, minimum 3 days a week onsite (will depend on the week based on having to perform testing)
Top Skills:
- Mechanical or Biomedical Engineering
- Experience planning, leading and executing design verification and design validation
- Experience in setting / defining a product specification
Primary Responsibilities:
- Plan and manage medium sized projects, as asked by the project team, and/or provide design technical guidance and consultation throughout cross-functional team projects to ensure effective planning, execution, and completion
- Create simulated use test plans/protocols, build prototypes, perform and/or oversee testing, analyze and document results, and create reports for design characterization, verification, and validation
- Prepare technical basis and justifications
Target Years of Experience: 7 years engineering total, with at least 4 years in medical device industry
Description:
Design, develop and provide technical expertise in the research and development (R&D) of peripheral vascular medical devices from conception to market release. Support engineering teams through planning, prototyping, literature review, performing testing and analysis, and troubleshooting. Partner with Quality, internal Manufacturing, Suppliers, Marketing, Regulatory Affairs, and other key functions to achieve business goals. This role leads medium projects requires effective management and prioritization of multiple concurrent projects and tasks in an ambiguous environment.
Duties:
- Plan and manage medium sized projects, as asked by the project team and/or provide design technical guidance and consultation throughout cross-functional team projects to ensure effective planning, execution, and completion
- Develop customer and product specifications
- Prepare technical basis and justifications
- Apply statistical, modeling, and structured problem-solving techniques and interpret results to promote the design of medical devices, problem-solving, or basis for change implementation
- Develop, troubleshoot, qualify, and/or validate fixtures, equipment, and test methods utilized to evaluate product design and performance while considering clinical relevance
- Coach, train, review and/or delegate work to lower-level specialists
- Prepare engineering drawings with specifications and tolerances
- Create simulated use test plans/protocols, build prototypes, perform and/or oversee testing, analyze and document results, and create reports for design characterization, verification, and validation
- Process engineering change orders
- Assist in developing Failure Modes, Effects, and Criticality Analyses
- Present technical findings or project status to cross functional teams through meeting minutes, presentations, design reviews and other means of communication
- Perform job functions in accordance with applicable GMP and ISO standards
- Maintain required documentation per GDP procedures
Must Have:
Requires a Bachelor’s Degree and minimum 7 years of relevant medical device industry experience, or advanced degree with a minimum of 5 years of relevant medical device industry experience.
Nice to Have
- Degree related to Mechanical or Biomedical Engineering
- Experience in medical device industry with Class III product and technologies
- Working knowledge of rapid prototyping and product design
- Experience with equipment and fixture development and qualification, test method development and validation (including clinically relevant methods)
- Experience with design characterization, verification, and validation (including pre-clinical animal studies)
- Ability to compile, organize, and communicate technical data using Excel, Word, Visio, and PowerPoint
- Experience using statistical techniques and software (e.g. DOE, Monte Carlo, ANOVA, Gage R&R, or Six Sigma tools and principles, and software – Minitab or JMP)
- Experience creating engineering models and using common engineering software (e.g. CAD, MATLAB, PLM – Agile, Enovia or Windchill)
- Experience working with Design for Manufacturing and Assembly or Design for Reliability and Manufacturability (or equivalent)
- Project or Program Management experience or PMI PMP certification