Principal Engineer
Principal Engineer
Posted on :
10-05-2025
Employer Active
1 Vacancy
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Job Description
Details:
Stefanini Group is hiring!
Stefanini is looking for Principal Engineer forPlymouth MN location (Hybrid Work)
For quick Apply please reach out to Gurvinder Singh Bali /
Open for W2 candidates only!
**Workers can be remote/hybrid but must be local and able to come into the office at least three days a week**
- This section focuses on the main purpose of the job in one to four sentences.
- Leads design and development of product changes within sustaining engineering for disposable medical devices.
- Schedule budget and lead engineering projects with minimal guidance.
- Serve as the technical expert for design change programs. (e.g. new products suppliers materials labeling CAPA/NCR cost reduction remediation).
- Identify investigate and solve complex engineering problems utilizing riskbased and customer focused approaches and engineering tools. (e.g. dFMEA Human Factors Engineering statistical software CAD).
- Lead the creation and maintenance of design history files.
- Coordinate and communicate the efforts of R&D in collaboration with global crossfunctional stakeholders.
- Adhere to design control procedures general safety rules company policies and procedures FDA and international regulations and guidance.
- May supervise engineers and/or technicians.
- May contribute to client intellectual property through invention disclosures and patent applications.
Details:
- Experience and/or Background BS in Mechanical Plastics Biomedical Engineering or a related field MS preferred.
- 5 8 years of related experience in Class II or Class III disposables medical product development.
- Advanced knowledge of plastics materials and processing such as injection molding extrusion ultrasonic welding UV/solvent bonding and sterilization.
- Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
- Working knowledge of CAD design and PDM enterprise software (e.g. Creo Solidworks).
- Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices Application of Risk Management to Medical Devices.
- Creative Problem Solver identify technical risks up front develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.
- Takes initiative with a high aptitude for learning innovation and implementing best practices and continuous improvements.
- Ability to train and coach others from technical expertise.
- Selfdirected resourceful and able to manage multiple priorities.
- Strong interpersonal communication collaboration and influencing skills.
- Ability to read write and comprehend English.
Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those facetoface conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group:
The Stefanini Group is a global provider of offshore onshore and near shore outsourcing IT digital consulting systems integration application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas Europe Africa and Asia and more than four hundred clients across a broad spectrum of markets including financial services manufacturing telecommunications chemical services technology public sector and utilities. Stefanini is a CMM level 5 IT consulting company with a global presence. We are CMM Level 5 company.
#LIONSITE
#LIGB1
Required Experience:
Staff IC
Employment Type
Contract
Key Skills
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