Job Description
This exciting opportunity is located in Plymouth, MN, a vibrant hub for innovation and technology. Join a team dedicated to advancing healthcare solutions and making a difference in patients'lives.
Must Have:
- Bachelor’s degree (minimum) in Engineering or Scientific discipline and 0-2 years of technical engineering experience
- Strong technical writing, analytical, and problem-solving skills
- Working knowledge of QMS requirements and document control processes
- 0-2 years of experience with testing and data analysis, creating test protocols and reports
- Engineering experience in medical device, regulated manufacturing, or related industry
- Experience supporting TMVs, PPAPs, IQ/OQ/PQ activities, or equipment validations
- Experience with validation activities, technical documentation, and regulated quality systems
- Familiarity with design verification, test methods, equipment qualification, or process validation
- Hands-on laboratory or manufacturing support experience
This engineer will support the PTA and Procedural Support portfolio within our R&D Released Product Management (RPM) team in the Peripheral Vascular Health Operating Unit. The role involves execution of product and process development activities, technical documentation, validation efforts, and cross-functional collaboration. Ideal for an engineer eager and quick to learn, who enjoys hands-on technical work, and is motivated by contributing to projects and teams that directly impact patients.
Key Responsibilities:
- Support execution of technical strategies and deliverables for the PTA and Procedural Support portfolio within the R&D RPM group
- Execute and support test strategies, including development, coordination, and completion of testing activities
- Perform hands-on laboratory and product evaluation work to build technical understanding of products and associated therapies
- Develop understanding of product functionality through test methods (TM), technical documentation, and product evaluations
- Execute Test Method Validations (TMVs) in accordance with applicable procedures and regulatory requirements
- Support Production Part Approval Process (PPAP) activities and associated documentation requirements
- Route, review, and approve technical reports while ensuring compliance with Quality Management System (QMS) procedures and documentation standards
- Collaborate with Regulatory Affairs to understand submission strategies and support regulatory documentation needs
- Support cross-functional teams to ensure project timelines, compliance requirements, and operational objectives are achieved
- Design, develop, analyze, troubleshoot, and provide technical skills during research and/or product development
- Design studies to investigate specific life science questions within the field of expertise
- May be involved in product research and development and/or clinical trials
- Translate research discoveries into usable and marketable products
Numbers & Facts
| Location | Plymouth, MN |
| Industry | Staffing/Employment Agencies |
| Salary | $30 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Analysis Skillsunmatched
- Biologyunmatched
- Cardiovascularunmatched
- Clinical Trialunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Design Verificationunmatched
- Document Controlunmatched
- Documentationunmatched
- Documentation Standardsunmatched
- Engineeringunmatched
- Functional Testingunmatched
- Healthcareunmatched
- Identify Issuesunmatched
- Laboratory Analysisunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Medical Equipmentunmatched
- Problem Solving Skillsunmatched
- Process Developmentunmatched
- Process Validationunmatched
- Product Developmentunmatched
- Product Managementunmatched
- Product Testingunmatched
- Production Part Approval Process (PPAP)unmatched
- Production Supportunmatched
- Quality Assurance Methodologyunmatched
- Quality Managementunmatched
- RPMunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Requirements Managementunmatched
- Research & Development (R&D)unmatched
- Research Skillsunmatched
- Support Documentationunmatched
- Technical Deliveryunmatched
- Technical Researchunmatched
- Technical Strategyunmatched
- Technical Supportunmatched
- Technical Writingunmatched
- Test Dataunmatched
- Test Plan/Scheduleunmatched
- Test Strategyunmatched
- Testingunmatched
- Validation Documentationunmatched
- Writing Skillsunmatched
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