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embecta Sr Manager, Systems Engineering - Subsystem in Andover, Massachusetts

embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and  Twitter .

The Senior Manager, Systems Engineering will provide leadership to System Engineering discipline in the design and development of embecta’s products. The candidate will manage multiple pillars of System Engineering and enroll the Systems team members to act as the hub of product development within the R&D organization.

The Senior Manager will lead System Engineering team members and all related activity including management, schedule, and budgetary responsibilities. In this key strategic and technical leadership role, additional responsibilities will be to ensure collaboration with peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs, Operations, Medical Affairs and Regulatory functions as well as any other key stakeholders.

RESPONSIBILITIES:

  • Lead and manage System Engineering R&D teams in embecta with a focus on Subsystem Architecture. This includes all aspects of R&D talent management such as ensuring the right people, right roles and right capabilities are based on the portfolio priorities. Actively develop and mentor systems engineers to develop a strong technical talent bench.

  • Manage the development of hardware and software enabled systems, those that interact with human or machines and functional activities relevant to achieve these goals. This includes driving functional excellence in identifying, breaking down and solving technical problems associated with design and development of system architectures, testing, product and other system engineering aspects for insulin delivery platforms.

  • Manage the following system engineering activities: product requirements, product architectures, FMEA content, animal studies, benchtop studies, early product evaluations, product technical issue management and root cause investigation.

  • Maintain close cooperation and coordination with the software, electrical, mechanical, and V&V teams in R&D and drive collaboration with internal (e.g. other embecta business units) and external partners. Identify and leverage synergies, expertise, and resources when appropriate.

  • Work with outside contract development groups and the ultimate transfer to internal resources for successful product launches.

  • Lead technical assessments and provide direction across multiple product development projects.

  • Create a team culture that supports open communication, collaboration across teams and empowerment to employees

  • Ensures that architectural components of subsystems are integrated, and components or subsystems are combined and problems in their interactions are addressed correctly.

  • Ensure compliance with embecta quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.

  • Attract, develop and retain the best talent to ensure the highest standard of excellence in industry research and development resulting in accelerated delivery of meaningful innovations to patients globally.

  • Provide management for direct reports, creating a culture of Accountability, Customer Focus, Teamwork, and Execution. Communicate job expectations and develop individual impact goals. Create development plans, coach and counsel associates as needed. Provide feedback and appraisals. Ensure compliance with corporate policies, procedures and productivity standards

  • Partner internally and externally to implement best practices, regulatory standards, and guidelines to generate high quality information to ensure innovative device design to meet unmet medical needs in alignment with the embecta mission.

EXPERIENCE & EDUCATION:

  • Minimum of a Bachelor’s degree in System Engineering, Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, Biomedical Engineering, or a closely related technical degree is required. Graduate degree in these fields are preferred.

  • Minimum 10 years of experience in engineering/technical field, at least 5 of which must be focused on complex system level work, with a significant focus on medical devices.

  • Minimum of 3 years of experience in people management.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Established expertise in areas including system modelling, system analysis, risk management, user needs research

  • Excellent verbal and writing skills as well as presentation expertise to senior level leadership.

  • Advanced leadership, interpersonal and influencing skills.

  • Organizational awareness and ability to garner support at all levels for a course of action.

  • Strong experience with relevant medical device standards, including IEC 62304 and IEC 60601, ISO 13485, ISO 14971, FDA Guidance for Design Controls, EU MDR, CE.

  • Demonstrated breadth and depth of technical, organizational and leadership capabilities, including strengths in most of the competency areas listed below and solid product development knowledge and expertise.

embecta is an Equal Opportunity/AffirmativeAction 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.

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