R&D Engineer

2 weeks ago

St Paul, United States Laborie Medical Technologies Corp Full time

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 our R&D team, the R&D Engineer will play a crucial role in providing PLM and R&D support to the existing products of our Interventional Urology Global Business Unit as well as performing engineering activities in support of new product development and product acquisitions at Laborie. The primary focus of the position will be to support the R&D deliverables for Drug Coated Balloon (DCB) design and related process at our facility located in Plymouth, MN. About the Role: Develop and advance knowledge of the Design Controls process according to 21 CFR 820 and ISO 13485; perform risk assessments per ISO 14971 and generate the Risk Management File. Project management for engineering changes or projects where a small project team is required to achieve project goals; drafting technical reports and lab notebook studies to support projects. Product testing to support R&D projects and other cross-functional projects (manufacturing, quality, PLM). Develop design control deliverables including creation of design inputs and outputs, traceability matrix, design history file, specifications, drawings, and other documentation relevant to the product as defined by the quality system. Responsible for supporting activities on new product development including design, prototyping, testing, human factors engineering, design verification and validation, design for manufacture/manufacturing transfer, packaging verification and validation. Minimum Qualifications: 2-4 years experience and Bachelor's in Mechanical Engineering, Biomedical Engineering, Material Science & Engineering or closely related engineering degree. Experience working in highly regulated industry such as medical device or pharmaceutical. Ability to lead, work with multi-disciplinary teams, and work with minimal supervision. Technical aptitude, "hands-on" approach to engineering, with a good understanding of engineering concepts, design for manufacturing, and experience with statistics and design of experiments. Knowledge of applicable standards/regulations such as GMP, EU MDD/EU MDR, 21 CFR 280 and ISO 13485. 3D CAD software skills (Solidworks) Preferred Qualifications: Experience with catheter manufacturing, including drug coated balloon catheters. Self-starter, willing to learn and work in fast-paced environment. 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 2023 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.

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