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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 (http://twitter.com/embecta) .

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.

Reporting to the Vice President of Quality, the Sr. Manager of Design Assurance, will lead and build a dynamic medical device design assurance team focused on standardizing and deploying best in class processes that include the design and development of embecta's diabetes care medical device worldwide. This person will lead the engagement and interaction with key internal customers specifically R&D, Quality Systems, Regulatory Affairs, Operations Quality, and Post Market Surveillance teams along with key external customers. This leader will drive alignment on quality related processes, targets, and goals. You will be a member of the global quality senior leadership team and support and lead global initiatives and ensure successful outcomes for global quality initiatives and programs. This role is crucial in overseeing and driving sustaining projects for the existing product portfolio and will play a key role in ensuring ongoing product quality and compliance. The primary responsibilities include enhancing design quality assurance processes, spearheading quality engineering and design assurance initiatives, and collaborating with cross-functional teams to foster continuous improvement.

_RESPONSIBILITIES:_

The Senior Manager of Design Assurance will be responsible for leading and managing the following activities:

+ Lead the implementation and governance of design control processes in compliance with quality standards such as 21 CFR 820.30, ISO 13485, and ISO 14971.

+ Champion the development and maintenance of risk management files per ISO 14971, ensuring complete traceability from hazard identification to risk mitigation and post-market surveillance.

+ Act as the quality voice in design reviews, ensuring that Critical to Quality attributes are defined, validated, and monitored.

+ Implement Design for Reliability (DfR) and Design for Manufacturability (DfM) principles in collaboration with R&D, Operations and Supply Chain for embecta product.

+ Improve the change control process by streamlining procedures and processes to ensure thorough documentation and communication of changes.

+ Implement quality improvement initiatives. Initiatives should focus on enhancing quality compliance, efficacy and safety of embecta’s products by streamlining processes, and reducing process defects or non-conformities.

+ Establish excellent working relationships with quality, R&D, operations, regulatory, and commercial teams to ensure successful transitions from product development projects into commercial operations.

+ Collaborate with suppliers to ensure the quality of materials and components used in product development.

+ Engenders cooperation between teams to enable issue resolution

+ Serve as a facilitator and mentor to subordinates and fellow co-workers, retain/build organizational talent

+ Successfully mentor and develop the design assurance team by providing training, guidance, and support, fostering a collaborative and innovative work environment

People Manager Core Competencies

The ideal candidate will develop talent with integrity, transparency, and a focus on measurable outcomes. They will incorporate external perspectives, foster creativity, and collaborate effectively, ensuring inclusivity and continuous improvement. In organizational design and succession planning, they will maintain ethical standards, adapt to industry trends, and engage team members, promoting a culture of inclusivity. Effectively carries out the expectations of People Managers as defined in company’s people leadership expectations. Among others this includes maintaining regular, at a minimum once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets. Managing performance issues and conflict proactively uses judgement in consulting with department leadership and Human Resources. Responsibility for the team´s compliance in terms of training, and fulfilment of their tasks and objectives as well as onboarding of new employees and development of the existing team

Customer Focus

+ The ideal candidate will prioritize the customer's perspective in strategic decisions, craft service practices that meet customer needs, and continuously seek ways to improve satisfaction. They will encourage experimentation, collaborate with team members, and value diverse customer perspectives. **Decision Making**

+ The ideal candidate will gather and analyze information ethically, consider external data, and make timely decisions based on clear criteria. They will involve team members and ensure decisions reflect diverse perspectives. **Driving Innovation**

+ The ideal candidate will inspire ethical innovation, encourage novel solutions, and promote experimentation. They will foster a culture of creativity, collaborate to drive innovation, and ensure inclusivity. **Emotional Intelligence Essentials**

+ The ideal candidate will establish trusting relationships, accurately interpret emotions, and manage responses effectively. They will continuously improve emotional intelligence skills, build strong relationships, and ensure practices remain inclusive and respectful of diversity.

Basic Requirements:

+ Bachelor of Science in Scientific, Technology, Engineering, Mathematics or related discipline.

+ 10+ years of experience in quality engineering or design assurance within the medical device, pharmaceutical, biologics, or related FDA regulated industry.

+ 5+ years in a leadership role with demonstrated progressive responsibility overseeing quality engineering or design assurance teams.

+ Proven track record in leading design assurance initiatives in a medical device company, demonstrating the ability to drive quality improvements and ensure product reliability.

+ Demonstrated ability to implement quality improvement processes and methodologies, such as Six Sigma and Lean, to enhance product quality and operational efficiency.

+ Experience in implementing and optimizing QMS tools (e.g., TrackWise, SAP, PLM systems) to support design control, CAPA, and risk management processes.

+ Hands-on experience with statistical analysis tools and methodologies such as Design of Experiments (DOE), Statistical Process Control (SPC), and Measurement Systems Analysis (MSA).

+ Demonstrated success in leading design assurance activities for medical devices, including design controls, risk management, verification/validation, and product release.

+ Extensive knowledge of FDA and international regulations.

+ Expertise in ISO 13485, and ISO 14971, including other relevant standards for embecta products.

+ Proven experience with risk management and failure mode effects analysis (FMEA), identifying potential risks and implementing strategies to mitigate them.

+ Ability to manage multiple projects simultaneously, including planning, executing, and monitoring project progress to ensure timely and successful completion.

+ This role will have around 10% travel.

Preferred Requirements:

+ Master of Science degree preferred.

+ Preferred certifications include Six Sigma, ISO 13485, and ASQ Quality Engineer and/or Certified Quality Manager.

+ Strong leadership skills with experience in mentoring and developing quality teams, fostering a culture of quality and continuous improvement.

+ Expertise in identifying and mitigating risks related to product quality and regulatory compliance.

+ Professional communication and presence.

+ Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, as well as executive management.

_Competitive base salary based on experience and qualifications: $137,100-181,650 (subject to variation depending on physical location)._

_Posted salary ranges are provided in good faith. embecta reserves the right to adjust ranges depending on the selected candidate’s experience, qualifications, external market conditions, and internal equity considerations._

_Base pay is one component of the Total Rewards package at embecta, which also includes eligibility for 15% bonus and an annual LTI award. Benefits include medical, dental, vision, retirement savings plans, and paid time off. More details about our benefits programs can be found on our Careers page_

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.