Principal Engineer (Hybrid)
Principal Engineer (Hybrid)
Posted on :
23-06-2025
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1 Vacancy
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Job Description
For further inquiries regarding the following opportunity please contact our Talent Specialist
Hema Malini at
Hema Malini at
Title: Principal Engineer (Hybrid)
Location: Hybrid in Plymouth MN
Duration: 12 Months
Location: Hybrid in Plymouth MN
Duration: 12 Months
Contract to Hire role
Position can be remote/hybrid but you must be local and able to come into the office at least three days a week
Description:
Summary:
- 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.
Essential Duties and Responsibilities:
- This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
- 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 risk-based 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 cross-functional 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 Clients intellectual property through invention disclosures and patent applications.
- The Principal Engineer will act as a technical lead on the disposable project supporting the day-to-day execution and oversight of engineering activities related to medical device product support.
- Strong understanding of product assembly processes change control and medical device manufacturing.
- Proven experience in design transfer from R&D to manufacturing
- Strong understanding of product assembly and manufacturing operations
- Familiarity with Design History Files (DHF) and product specifications
- Experience in remediation projects is highly desirable
- MDR (Medical Device Regulation) experience is a plus
- Experience working with or supporting manufacturing plants
Qualifications:
- To perform this job successfully an individual must be able to perform each essential duty satisfactorily. List knowledge skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- 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.
- Self-directed resourceful and able to manage multiple priorities.
- Strong interpersonal communication collaboration and influencing skills.
- Ability to read write and comprehend English.
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.
Interview: 2 rounds (MS teams Onsite) Video Panel if Non-Local.
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full Time
Key Skills
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