Senior Product Engineer

Embecta Corp.; Leinster; On-site; EUR 85,000 - 120,000; Full time

Job summary

embecta is seeking a Senior Product Engineer to support global Product Engineering across development, regulatory, marketing, and operations. You will drive lifecycle projects, lead change controls, and ensure regulatory and quality compliance for diabetes devices.

The role collaborates with manufacturing for problem solving, maintains design history, and conducts competitive analysis and device testing to provide critical market insights.

Qualifications

• Bachelor's degree in Engineering or Science; Mechanical, Biomedical or Chemical preferred.
• PM qualification is an advantage and desirable.
• 5+ years in medical device design or R&D with market delivery experience.
• Experience with medical product design, research and development.
• High volume manufacturing experience preferred.
• Knowledge of polymer materials and injection molding.
• Design verification
• GD&T
• 3D CAD modeling
• Statistical analysis
• Test method validation
• Project Management

Responsibilities

• Plan and execute product lifecycle R&D projects impacting form/fit/function and compliance.
• Lead projects through change control processes.
• Communicate updates to cross-functional stakeholders.
• Ensure compliance with local and international quality and safety regulations.
• Collaborate with manufacturing plants to resolve issues.
• Maintain design history files for products and extensions.
• Conduct competitive analysis and device compatibility testing.
• Design test equipment and validated procedures to demonstrate compliance (ISO, etc).

Skills

Project Management

Statistical analysis

Design verification

Risk management

Education

Bachelor's degree in Engineering or Science

Project Management qualification

Tools

GD&T

3D CAD modeling

Injection molding

Job description

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.

The Senior Product Engineer will be an integral part of the product lifecycle engineering team responsible for supporting the various product lines in the $1 Billion embecta diabetes business. The Senior Product Engineer's primary role would be to provide support on a global basis for Product Engineering working closely with product development, regulatory affairs, marketing, operations, manufacturing plants, and quality.

Responsibilities

• Utilizing best-in class project management practices, plan and execute product lifecycle engineering R&D projects which impact form/fit/function, business growth, cost reduction and compliance.
• Lead engineering projects through embecta's change control processes.
• Communicate project updates and escalations as appropriate to line management and to cross functional stakeholders within the embecta business.
• Ensure compliance with all local, international and embecta quality and safety regulations, policies, and procedures.
• Collaborate with manufacturing plants to assist in problem solving and issue resolution.
• Augment and maintain robust design history files for the current diabetes products and line extensions.
• Plan and conduct ongoing competitive product analysis and device compatibility testing to provide key insights into the competitive landscape and device compatibility.
• Design test equipment and create validated test procedures for product testing to demonstrate compliance with internal and external requirements, such as ISO standards.

Education & Experience

• Bachelor's degree in Engineering or Science, preferably in Mechanical, Biomedical, or Chemical Engineering.
• Project Management qualification an advantage
• 5+ years' experience in medical device design or R&D with a successful track record of delivering products to market and successfully supporting products in the market after launch.
• Medical product design, research, and development.
• High volume manufacturing desired
• Polymer material science and injection moulding processes.
• Design verification
• GD&T 3D CAD modeling.
• Statistical analysis
• Test method validation
• Project Management

embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.