R&D Engineer II

Laborie; Maple Grove (MN); Presencial; USD 85 000 - 125 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid time off

Medical, dental, vision

Health Savings Account with company$

401k with company match

Parental leave

Wellness programs

Resumo da oferta

Laborie is seeking an experienced R&D Engineer II to support PLM, sustaining, and new product development for consumable medical devices. You will handle design changes, material changes, and validation activities across the product life cycle, including usability and regulatory considerations.

You will collaborate with manufacturing, qualify vendors, and drive documentation in DHF, IQ/OQ/PQ, and risk management. Travel up to 25% is expected.

Qualificações

• 5+ years of R&D or Sustaining Engineer experience in medical devices.
• BS degree in biomedical, mechanical, chemical engineering or related field.
• Experience with design controls, FDA/QSR and ISO requirements.

Responsabilidades

• Lead design changes and documentation to support NPD and sustaining products.
• Develop test methods, perform verification/validation, and manage DHF.
• Collaborate with manufacturing and contract vendors for equipment qualification.
• Plan IQ/OQ/PQ, risk management, and data analysis for regulatory submissions.
• Create manufacturing documents and SOPs; ensure compliance with EU MDR, ISO, FDA.

Conhecimentos

SolidWorks

CAD design

Design controls

FDA regulation

QSR requirements

Root Cause Analysis

Statistical analysis

Design for manufacturability

Vendor collaboration

Formação académica

B.S. in Biomedical Engineering

B.S. in Mechanical Engineering

B.S. in Chemical Engineering

Ferramentas

SolidWorks

CAD software

test fixtures

prototype fabrication

Descrição da oferta de emprego

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 team, the R&D Engineer II will be responsible for providing PLM (product lifecycle management) / Sustaining and R&D support to existing products in our consumables portfolio as well as performing engineering activities in support of new product development and product acquisitions including assembled molded parts and catheter based devices. This includes a wide variety of responsibilities including design changes, material changes, specification changes, packaging changes, in support of revenue, quality, cost reduction, production, and compliance goals.

About the Role:

• Responsible for activities on new product development and product/process improvement for consumable medical devices (Class I, II, and II) including design, prototyping, material selection, verification and validation, maintaining DHF documentation, and design for manufacturability/manufacturing transfer.
• Develop product test methods by studying product requirements; research, design, modify , and test medical devices including combination products.
• Collaborate with manufacturing to identify and qualify equipment vendors.
• Plan, document, and execute design verification and validations. IQ/OQ/PQ, draft protocol/reports, risk management ( dFMEA ), and statistical data analysis.
• Develop applicable manufacturing documents including MPs, IPs, LHRs, and material handling procedures. Prepare, review, and approve processes, protocols, reports, and other controlled documentation.
• Ensure processes and procedures comply with relevant regulations such as EU MDR, ISO, FDA, etc.
• Participate and aid in the full life cycle of product development – NPD and sustaining – including design changes, usability studies, market needs assessments, design for manufacturability, and process optimizations .
• Travel expectations up to 25% .

Minimum Qualifications:

• 5+ years' experience as a R&D or Sustaining Engineer preferably in Medical Devices or other regulated FDA/QSR and ISO environment
• BS degree in Biomedical, Mechanical, Chemical Engineering or related with 7+ years’ experience as a R&D Engineer in a n FDA/QSR and ISO environment
• Strong knowledge of injection molding and assembled consumable medical device technologies, processes, and associated requirements and/or experience designing catheters, associated manufacturing processes, and interfacing with contract manufacturers.
• Experience with SolidWorks, CAD design software, creating/fabricating test fixtures, prototypes and test fixture fabrication .
• Proven experience and knowledge of design controls, device design and development standards, FDA regulation, GMP practices and QSR requirements .
• Proven experience in the end‑to‑end development cycle, preferably with exposure to both small and large companies .
• Experience with Root Cause Analysis tools and methodologies, NCMR disposition and reviews .

Preferred Qualifications:

• Experience using statistical analysis to analyze data, Minitab experience preferred.
• Experience across full product life cycle – design and development, sustaining, and manufacturing .
• Trained in and uses Design For Six Sigma, Lean Six Sigma, DFM/A and GD&T principles to optimize product development.
• Experience creating 3D models and prints in SolidWorks .
• Leading successful product launches and regulatory submissions .

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 202 5 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.