R&D Engineer

An exciting opportunity is available for an R&D Engineer to join a fast-paced, collaborative team supporting new projects in process development for medical devices. This is a 6-month onsite assignment in Minnetonka, Minnesota, with potential for extension or conversion to a permanent role for high-performing individuals.

The successful candidate will be responsible for authoring and executing process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and related reports. Daily activities include hands-on testing and building of medical devices in laboratory or clean room environments, thorough documentation of testing procedures, and training operators on manufacturing processes. The role involves characterizing processes, identifying necessary inputs and outputs, and supporting continuous improvement initiatives through data analysis and presentation.

You will interact regularly with process development engineers and work cross-functionally with R&D, quality, manufacturing, and operations teams. Providing instruction to assembly operators and contributing to the development and revision of manufacturing documents, specifications, SOPs, safety instructions, and risk assessments are key responsibilities.

Candidates must have a bachelor's degree in mechanical, biomedical, chemical engineering, or a related field. 1-3 years of experience is preferred, ideally within the medical device industry. Strong problem-solving skills, self-motivation, and technical writing ability are essential. Experience with process validations (IQ/OQ/PQ), hands-on testing, and familiarity with CAD and statistical software such as Solidworks and Minitab are advantageous.

The team culture is social, outgoing, and values a good work-life balance. Success in this role requires the ability to work independently and collaboratively, delivering accurate results with minimal supervision.

Must-Have

Skills:

Technical Writing, Process Validation, Test Method Validation, Inspection Method Validation, Installation Qualification, Operational Qualification

Nice-to-Have

Skills:

IQ, OQ, PQ, CAD, Statistics, Windchill, Minitab, Solidworks, Medical device, Bachelor's degree, Problem Solving, Self-Driven, Hands-on, communicator

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.