Principal R&D Engineer

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.  

Why join us?  

A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day. 

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. 

主要职责KEY RESPONSIBILITIES:

• Provide technical direction and guidance for engineering projects, ensuring alignment with overall business goals and technical strategy.
• Lead the design, development and verification of new products and product updates throughout the development life cycle.
• Plan and execute sustaining engineering R&D projects which impact form/fit/function, business growth, cost reduction and compliance projects.
• Support the global roll out and commercialization of the products portfolio.
• Drive effective design and technology transfer from development to manufacturing by proactively working with stakeholders from manufacturing.
• Communicate project updates and escalations as appropriate to senior management and to cross functional stakeholders within the wider company products business unit.
• Ensure compliance with all international standards, quality and safety regulations, policies, and procedures.
• Collaborate with manufacturing plants to assist with product nonconformance issues and identify creative solutions to problems in a timely manner to process NC's and CAPA's.
• Augment and maintain robust design history files for current products and line extensions.
• Plan and conduct ongoing competitive product analysis and device compatibility testing to provide key insights into the competitive landscape.
• Design test equipment and create validated test procedures for product testing to demonstrate compliance with internal and external requirements such as ISO standards.
• Manage, coach, and mentor more junior team members as appropriate.

经验 & 学历EXPERIENCE & EDUCATION:

• The successful candidate will be educated to degree level in Engineering with Mechanical, Design, Biomedical being preferred.
• 10+ 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.

技能KNOWLEDGE, SKILLS AND ABILITIES:

• Clear understanding of medical device GMP, ISO 13485, EU MDD/MDR, CFR820 and other relevant regulations.
• Business fluency in Chinese and English, oral and written.
• Medical product design, research, and development.
• High volume manufacturing.
• Polymer material science and injection molding processes.
• Sustaining engineering activities post launch.
• Tolerance analysis.
• 2D drawing generation, GD&T.
• 3D CAD modeling.
• Fixture creation & development and test method development, implementation and validation (Gage R&R) for medical device/systems.
• Statistical concepts such as those used in measurement system analysis (MAS), the design of experiments (DOE), and validation.
• Quality management systems in a regulated environment.
• The stage gate processes and design controls used in medical product development.

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.