Senior Medical Device R&D Engineer - NPI & Mechanical Design

Solventum in; Eagan (MN); Híbrido; USD 106.000 - 146.000; Jornada completa

Descripción de la vacante

Solventum seeks a Sr. R&D Engineer focusing on IP&SS Mechanical Design Development. You will plan and independently execute work packages for new product introductions, translating user and regulatory needs into engineering specs and robust designs.

You will develop components, assemblies, and product architectures for performance, safety, reliability, and manufacturability, while collaborating with cross-functional teams and supporting manufacturing readiness.

Formación

• Bachelor’s Degree or higher AND (3) three years of professional experience in product development in medical device, healthcare or another regulated industry.
• Experience in GMP certified Manufacturing Processes.
• Working knowledge of design controls, risk management, verification and validation, and product commercialization processes.
• Knowledge of injection molding design, polymer materials, tooling, or high-volume manufacturing processes.
• Experience developing electro-mechanical systems, and disposable sensors.
• Familiarity with product lifecycle management, design history file documentation, and controlled engineering change processes.
• Demonstrated ability to apply engineering principles and structured problem-solving methods to complex product development challenges.
• Experience planning and executing technical work with increasing independence and accountability for results.
• Strong analytical skills and experience interpreting technical data to support decisions and recommendations.
• Ability to work effectively with multi-disciplinary and cross-functional teams.
• Self-driven, problem solving and critical thinking skills.

Responsabilidades

• Plan and independently execute technical work packages for new product introduction programs, including design, analysis, prototyping, testing, and design optimization.
• Translate user, customer, business, and regulatory needs into product requirements, engineering specifications, and practical design solutions.
• Developing and evaluating components, assemblies, subsystems, and product architectures for performance, safety, reliability, manufacturability, and cost.
• Analyzing data, interpreting test results, applying sound engineering judgment, and communicating evidence-based recommendations that support project decisions.
• Investigating product and process issues, identifying root causes, recommending solutions, and implementing improvements that reduce technical and business risk.
• Supporting NPI phase and gate reviews and contributing to project planning, technical decision-making, milestone delivery, and risk escalation.
• Creating and maintain design control documentation, technical reports, laboratory records, design outputs, test methods, protocols, reports, and other required project records.
• Participating in risk management, design verification, design validation, product release, and design transfer activities in accordance with applicable quality-system requirements.
• Collaborating with cross-functional core and extended team members, suppliers, and external partners to achieve committed project deliverables.
• Supporting manufacturing readiness, product commercialization, and transfer of product and design knowledge to manufacturing and sustaining engineering teams.
• Contributing to innovation and intellectual property through new product concepts, technical solutions, records of invention, patents, trade secrets, and proprietary know-how.
• Preparing and presenting technical updates, design reviews, reports, and recommendations to project teams, business stakeholders, customers, and technical communities as appropriate.

Conocimientos

3D CAD

Root cause analysis

Cross-functional teamwork

Analytical skills

Problem solving

Educación

Bachelor's Degree or higher

High School Diploma/GED with 10 years experience

Herramientas

Injection molding tooling

Polymer materials

PLM systems

Descripción del empleo

Solventum seeks a Sr. R&D Engineer focusing on IP&SS Mechanical Design Development. You will plan and independently execute work packages for new product introductions, translating user and regulatory needs into engineering specs and robust designs.

You will develop components, assemblies, and product architectures for performance, safety, reliability, and manufacturability, while collaborating with cross-functional teams and supporting manufacturing readiness.