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Company Contact Info
- Saint Paul, MN 55114
- Daphnne Vazquez
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Sr. Principal Engineer
Kelly Engineering Resources • Saint Paul, MN
Posted 6 days ago
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Work Location: Saint Paul, MN
Job Title: Sr. Principal Engineer
Duration: 12 Months (Temporary/Contract)
This position is responsible for supporting the activities of a Design Owning Organization located in St. Paul, MN facility. The candidate will work with the St. Paul Product Design Owners (PDOs) in performing tasks related to regulatory compliance, change control, design control, and risk management.
• Support the PDOs in fulfilling requirements for regulatory compliance, design control and risk management activities for medical products.
o Help ensure that design and development activities and documentation are within regulatory compliance, particularly for the new European Medical Device Regulation (MDR)
o Help maintain the Design History Files and Risk Management files for medical products
o Generate and manage work flow for appropriate change control documentation.
o Create and edit technical information, such as requirements, verification and validation protocols, and test methods
• Support the PDO in gathering information from Subject Matter Experts (SMEs) and technical resources for design testing, risk analysis, change control, and regulatory submissions
• Other tasks as needed
• Outstanding communication skills – both written and oral
• Organizational skills and attention to detail
• Ability to work effectively independently and in team environment
• Experience working in medical device development, design control and risk management is required
• Knowledge and experience working with medical device regulatory requirements
• Design History File remediation, and change control knowledge is desirable
EDUCATION / EXPERIENCE
• Bachelor's degree or higher in Biomedical, Biomechanical, Mechanical or similar engineering discipline with at least five years’ work experience in a medical or regulated industry
• Experienced with all typical software tools (MS Office Suite, Minitab, CAD SW – prefer SolidWorks)
• Regular attendance is necessary to perform the essential functions of the job.
• Sedentary work, lifting a maximum of 20 pounds; walking / standing occasionally.
• Normal office working conditions: computer, phone, files, fax, copier.
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.