Description
\t\t\t\t\tThis position involves synthesizing customer needs, business needs, and technology expertise into a system design and product development and implementation plans for the next generation of Inspire products. This position will focus on physical components of the Inspire System regarding internal design/development, design transfer, and support continuation engineering efforts as required.
\t\t\t\t\tSkills
\t\t\t\t\tproduct development engineering, mechanical engineering, Medical device, Design, Mechanical, Solidworks, Mechanical design, Iso 13485, Product design, Electro mechanical, root cause analysis, capa, validation, validation testing, electrical testing, New product development, Design for manufacturing, Iso 14971, Product design/development
\t\t\t\t\tTop Skills Details
\t\t\t\t\tproduct development engineering,mechanical engineering,Medical device,Design
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\t- Technical leadership related to product design including tasks such as establishing requirements, managing vendors, achieving project deliverables & timeline- Provide mechanical design and material expertise with a focus on implantable devices- Clearly communicate key technical updates to stakeholders- Lead the design & execution of structured experimental plans to drive data-based decisions via characterization, verification, and validation testing.- Solve engineering problems by analyzing the situation and recommending solutions or alternative actions- Lead product technical reviews and design reviews for products in development as well as post market products- Support or lead post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations- Create/Demonstrate a strong team culture around high expectations & performance- Create, control and store engineering parts and drawings within CAD Software database- Lead and/or support product level risk management activities in compliance with ISO 14971- Serve as mechanical engineering liaison to cross-functional partners to ensure project success- Generate and approve design history file documents, device master record documents, ECO records, and other quality system documents and records- Provide continuation engineering support for products including review of supplier change requests, non-conforming reports and temporary deviations- Work with contract manufacturers on process validation activities (IQ/OQ/PQ)- Support patient cases and Inspire customers- Develop, disclose, and support the patenting of innovative technology and solutions
\t\t\t\t\tExperience Level
\t\t\t\t\tExpert Level
Pay and Benefits
The pay range for this position is $155000.00 - $190000.00
- Multiple health insurance plan options
- Dental, Vision, Life and Disability benefits
- HSA with employer contributions
- 401K plan + employer match
- Flexible time off
- 16 paid holidays
- All employees have the opportunity to gain equity awards and Employee Stock
Workplace Type
This is a fully onsite position in Golden Valley,MN.
Application Deadline
This position will be accepting applications until Feb 1, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.