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166546,  Design Assurance Engineer - WI -

Category: ENG
Job Title: Design Assurance Engineer - WI
Region: WI-Wisconsin
City: Milwaukee
State: WI
Rate: $DOE
Duration: 6 months
Description: Chipton Ross is seeking a Design Assurance Engineer in Milwaukee, WI.

Position Summary:
The Design Assurance Engineer will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with Engineering teams in the development of medical devices to ensure safety and efficacy are demonstrated. At all times throughout the process, you will identify and mitigate risks.

Responsibilities:
o Provide Design Assurance support and oversight for product development activities throughout the product lifecycle.
o Ensures product development follows company procedures and design control requirements.
o Ensure compilation and maintenance of product Design History Files. Perform DHF audits as an independent reviewer.
o Drive robust design reviews within R&D teams.
o Review and approve Design Verification and Design Validation test protocols and reports.
o Document traceability of requirements through design output and to design verification and/or design validation.
o Oversee and ensure risk assessments adequately address safety and efficacy and are compliant with the highest standards. Promote a "do no harm culture".
o Leads the risk management process for pre-market and post-market assessments of assigned products. Maintains the Risk Management File during the product's lifecycle.
o Guide the use of robust statistical techniques throughout new product development and design changes.
o Supports external regulator or customer audits
o Performs other duties as requested.

Essential competencies:
o Bachelor of Science degree in Engineering or related field.
o 5+ years relevant work experience.
o Strong working knowledge of design controls as required by FDA 21 CFR 820.30 and ISO 13485
o Experience with software development processes is required
o Demonstrated ability to analyze, evaluate and control risk following lifecycle risk management standards (e.g. ISO 14971).
o Understanding of statistical analysis techniques and tools.
o ASQ or related quality certification is preferred.
o Work experience in an FDA regulated environment is preferred.
o Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.)
o Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc.
o Comfortable with using PC tools and Windows OS, with a working knowledge of local and network-based file systems.
o Excellent verbal and written communication skills using the English language.
o Able to coordinate multiple activities and actions of persons contributing to assigned tasks.
o Detail oriented with good organizational and record keeping skills.
o Ability to work independently and as part of a team.
o Proactive and timely in the execution of assigned tasks.
o Able to be flexible and adaptable when needs and priorities change

Education:
o Bachelor of Science degree in Engineering or related field.

Schedule:
o FT

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Chipton-Ross is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Contact:
Christophor Long at clong@chiptonross.com
CHIPTON-ROSS, INC.
6926 Rivers Ave
North Charleston, SC 29406

Phone: (843) 554-5800 x179 or (800) 927-9318 x179


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