Staff Engineer, R&D
Staff Engineer, R&D
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Job Description
JOB SUMMARY
At NP Medical our innovation comes from the creativity and efforts of our team which is backed by a trusted network of clinicians inventors partner companies and Staff R&D Engineer provides technical leadership and hands-on contributions throughout the product lifecycle to enable both the growth and maintenance of our medical device product portfolio. Primary responsibilities of the role include user needs assessment defining design inputs creating and refining product concepts and product specifications developing design verification testing protocols and executing design validation studies. Additional activities of importance include the support of design and process improvements for existing platforms and other post-launch product engineering initiatives. The individual must have a record of success within a medical device product development environment command of medical device design controls and related regulatory requirements a penchant for maintaining detailed documentation throughout all phases of research and development work effectively in cross functional teams and collaborate in a professional manner with internal and external stakeholders.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Staff Engineer with the support of team members will be responsible and accountable for the following areas of medical device product engineering within the fields of fluid / medicament administration and vascular access site management:
- Establishment of User Requirements and Design Inputs
- Ideation Concept Development and Feasibility Testing involving rigorous trade-off analysis
- Prototype Design including elements of Human Factors Engineering Formative Usability Testing Robust Design Analysis
- Design for Excellence w/ associated deliverables inclusive of DFMA for high-volume injection molding automation
- Alignment with Design Controls and Regulatory Requirements
- Test Method Development
- Design Verification and Validation
- Design Platforming and Issue Resolution
- Post-launch Product Engineeringand Manufacturing Support
JOB QUALIFICATIONS (EDUCATION EXPERIENCE KEY REQUIREMENTS)
- Bachelors degree in Engineering required; Mechanical Engineering strongly preferred
- Minimum of 7 years of medical device product development experience required; single-use disposables strongly preferred
- Proven leadership competencies
- Analytical thinker having a history of pragmatic solutions
- Strong ability to communicate technical advancements and issues to all stakeholder groups
- Must have working knowledge of FDA requirements including 21CFR820 ISO13485 ISO14971 CGMP and other standards as they relate to the design manufacture and risk assessment of medical devices
- Highly proficient in SolidWorks tolerance stack-ups geometric dimensioning and tolerancing
- Device development experience involving common medical device polymers and related processes
-Competent using statistical analysis software; Minitab preferred
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Jabil including its subsidiaries is an equal opportunity employer and considers qualified applicants for employment without regard to race color religion national origin sex sexual orientation gender identity age disability genetic information veteran status or any other characteristic protected by law.
Accessibility Accommodation
If you are a qualified individual with a disability you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to or calling with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.#whereyoubelong
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Required Experience:
Staff IC
Employment Type
Full-Time
