Design Verification Engineer, PLM
About this role
- Assist in managing the product life cycle of released product lines.
- Initiate, manage and deliver product changes to support sales, marketing, production, and service.
- Collaborate with new product development, manufacturing engineering, and quality engineering staff to ensure compliance of new or modified products and processes to company design control and quality system requirements.
- Provide technical support to regulatory affairs, customer care, and marketing staff for product support issues and country registration processes.
- Communicate and follow up on project details, milestones and expected outcomes to subcontractors.
- Maintain Design History Files and Device Master Records and other related documents, following product launch in accordance with company policy and procedures.
- Prepare test validation protocols, testing, results analysis, and report writing for product and/or process changes, including both internal and external testing.
- Develop and execute plans to address gaps and deficiencies, whether identified internally or as audit non-conformances.
- Bachelor’s degree in engineering - System, Electrical/Electronic, Mechanical and/or Biomedical or equivalent.
- 2+ years' experience in design, development, and testing in Medical, Automotive, Aerospace or similar industries
- Knowledge of Azure DevOps, JIRA, Greenlight Guru, or other test environment, SAP Business applications a plus
- Knowledge of applicable standards/regulations such as GMP, FDA's QSR (CFR 820), IEC 60601 and /or IEC 62304 EU MDD/EU MDR, and ISO 13485, and understanding of test method verification, validation, and analytical methods
- Good understanding of/familiarity with engineering concepts including design for excellence, CTQ design and development, and engineering change process
- Must be highly organized with well-developed time-management skills and the ability to manage multiple priorities simultaneously in a rapidly changing environment.
- Excellent communication skills, attention to detail, commitment to quality, ability to work on multiple projects concurrently, and technical aptitude "hands-on" approach to engineering.
- Paid time off and paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events
- Awarded 2025 Cigna Healthy Workforce Designation Gold Level
Company at a glance
Laborie is a world-class specialist medical company that makes and advances technologies that preserve and restore human dignity. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. Our technologies include diagnostic equipment and consumable supplies in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields.
Privately owned by Patricia Industries and a part of the Investor AB network, Laborie is comprised of powerful brands that have been cultivated for more than 50 years. As a rapidly growing and scaling organization, our company values drive our day-to-day behaviors and make us ONE Laborie whenever and wherever we do business. We know that the work we do matters and we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.
If you’re ready to be part of a mission with meaning and a rewarding environment with opportunities for professional growth and career advancement, view our current job openings at https://www.laborie.com/about-us/careers/
Top Benefits
- Paid Time Off
- Paid Volunteer Time
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Account
- Health Savings Account
- 401k Retirement Plan
- Parental Leave
- Adoption Services
- Health And Wellness Programs
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