The Role
Supports the design verification, testing, integration, maintenance, and lifecycle management of medical device product lines. Responsibilities include managing product changes, preparing validation protocols and reports, maintaining Design History Files and Device Master Records, supporting regulatory registrations, investigating failures, coordinating subcontractors, and addressing audit deficiencies. The role collaborates with R&D, manufacturing, quality, regulatory, marketing, and customer care teams to ensure compliance with design controls and quality-system requirements.
Summary Generated by Built In
We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We’re Looking For:
As a key member of the R&D PLM Engineering team, the Design Verification Engineer is responsible for various engineering activities to support ongoing improvements and maintenance of current product lines in the Laborie Portfolio. This includes detailed design verification documents, testing, and integration of software/hardware/firmware components, product assemblies, procedures for products, design changes, DHF & DMR updates, support to country-specific registration requirements, failure investigations, design transfers, and product obsolescence management.
About the 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.
Minimum Qualifications:
- 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.
Why Laborie:
Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
- 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
Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.
Skills Required
- Bachelor’s degree in systems, electrical/electronic, mechanical, biomedical, or equivalent engineering
- At least 2 years of experience in design, development, and testing within medical, automotive, aerospace, or similar industries
- Knowledge of applicable standards and regulations, including GMP, FDA QSR CFR 820, IEC 60601, IEC 62304, EU MDD, EU MDR, and ISO 13485
- Understanding of test method verification, validation, and analytical methods
- Familiarity with design for excellence, CTQ design and development, and engineering change processes
- Strong organization, time management, communication, attention to detail, and ability to manage multiple concurrent projects
- Knowledge of Azure DevOps, JIRA, or Greenlight Guru
- Knowledge of SAP Business applications
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The Company
What We Do
Laborie develops innovative medical technologies – including diagnostic equipment and consumable supplies – in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. LABORIE is comprised of a variety of powerful brands – cultivated over more than 50 years of providing innovative products and services to our customers. Our story is one of continuous profitable growth, driven both organically and inorganically through mergers and acquisitions. We are privately owned by Patricia Industries and a part of the Investor AB network. Our owners take a long-term investment approach and create value for people and society by building strong and sustainable businesses. We know the work we do at LABORIE matters – we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.
