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Job Details
Administrative
Principal Engineer - Plymouth, MN
Posted: 5/7/2025
Job ID#: 60420
Category: Administrative
Type: Contract
Duration: Long Term
Shift: 1
Remaining Positions: 1
Stefanini Group is hiring! We are seeking a Principal Engineer for our Plymouth, MN location (Hybrid Work). For quick application, contact Gurvinder Singh Bali at 248 263 8629 or gurvinder.bali@stefanini.com. Open to W2 candidates only. Candidates should be local and able to work in the office at least three days a week.
Job Responsibilities
* Lead design and development of product changes within sustaining engineering for disposable medical devices.
* Manage scheduling, budgeting, and lead engineering projects with minimal guidance.
* Serve as the technical expert for design change programs, including new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
* Identify, investigate, and solve complex engineering problems using risk-based and customer-focused approaches (e.g., dFMEA, Human Factors Engineering, CAD).
* Maintain and create design history files.
* Coordinate R&D efforts with global cross-functional stakeholders.
* Ensure compliance with design control procedures, safety rules, company policies, FDA and international regulations.
* Potentially supervise engineers and technicians.
* Contribute to intellectual property through invention disclosures and patents.
Job Requirements
* Bachelor's in Mechanical, Plastics, Biomedical Engineering or related field; Master’s preferred.
* 5-8 years of experience in Class II or III disposable medical product development.
* Expertise in plastics materials and processing (e.g., injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization).
* Knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
* Proficiency in CAD design and PDM software (e.g., Creo, SolidWorks).
* Understanding of ANSI/AAMI/ISO 14971 Medical Devices - Risk Management.
* Creative problem-solving skills and initiative for continuous improvement.
* Ability to train and mentor others.
* Self-directed, resourceful, with good multitasking skills.
* Strong interpersonal and communication skills.
* Proficiency in English reading, writing, and comprehension.
Salary ranges may vary based on experience and market. Some positions may include bonuses or incentives.
Stefanini values top talent and transparent hiring processes, including thorough conversations about the role, interviews, and offers.
About Stefanini Group
We are a global provider of IT consulting, outsourcing, and staffing services, serving Fortune 1000 clients worldwide across various industries. We are a CMM Level 5 company with a strong global presence.
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Pay Range: $45.00 - $50.00
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