- Assist in managing the product life cycle of current product lines.
- Design, implement, 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.
- 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, and 2+ years of experience in the design, development, and testing of medical devices.
- Knowledge of Azure DevOps, MTM, Greenlight Guru, or another test environment is required.
- 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.
- Candidate must be highly organized with well-developed time-management skills and the ability to manage multiple priorities simultaneously in a rapidly changing environment.
- Good understanding / Familiarity with engineering concepts including design for excellence, CTQ design and development, and the engineering change process.
- Strong analytical and problem-solving skills and excellent attention to detail and a commitment to quality
- Excellent communication skills, ability to work on multiple projects concurrently, and technical aptitude "hands-on" approach to engineering.
- Knowledge of SAP Business applications is a plus.
- Experience working in a medical-regulated industry with user/patient safety is preferred.
- 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
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Design Verification Engineer - Portsmouth, United States - Laborie Medical Technologies Corp
Description
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 team, the Design Verification Engineer is responsible for the various engineering activities to support ongoing improvements and maintenance of the current product lines in the Laborie Portfolio. This includes aspects including a detailed design verification plan, testing, and integration of hardware/mechanical components, assemblies, and 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:
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.
