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 Sr. Manager, R&D – Mechanical Engineering will lead a team focused on product development of large complex new-to-world product development platforms that help people live healthier lives. The successful candidate will be responsible for leading the Mechanical Engineering team for the development of disposable electromechanical drug delivery devices to enable solutions for chronic disease management and other wearable applications. The role will participate in executing technical and cross-functional project work, which includes all phases of product development, including design and development planning, requirements definition, product development, operations development, root cause analysis, test method development, design verification/validation and reliability.

RESPONSIBILITIES:

• Through direct management as well as subordinates, this leader will define work roles and oversee Mechanical Engineering activities

• The position will ensure associates follow applicable embecta procedures in the day-to-day activities of team members and ensure the Mechanical Engineering team has the necessary skills and resources to execute on developing assigned projects

• Create and maintain a strong multi-faceted Mechanical Engineering team of design and development resources

• Ensure quality completion and accuracy of project deliverables including design control elements and applicable regulations from definition of requirements and technical inputs, design elements and technical outputs, and verification and validation that the designs meet requirements

• Provide necessary supporting data for regulatory submissions for product clearance

• Manage R&D projects including schedule creation, management, budgets, and communication to core team and senior leaders

• Communicate and implement strategic technical direction for programs

• Identify issues with projects or associates, communicate issues, and take appropriate action

• Provide mentoring, feedback and conduct year-end reviews with reports

• Lead mechanical/electromechanical design of disposable systems/products

• Support development of manufacturing equipment and processes

• Use first principles and advanced engineering methods to guide the development process

• Perform 3D modeling and analysis of complex electromechanical systems using Solidworks

• Perform design reviews, lead efforts in creation of technical specifications and test methods for new products

• Work with upstream and downstream stakeholders to create designs that meet customer expectations and high-volume manufacturing requirements

EXPERIENCE & EDUCATION:

• Bachelor’s degree in Mechanical or Electromechanical Engineering or related field

• 8-10 years of professional experience leading or supporting product development projects

• Six Sigma certification training or experience

• Strong project management skills

• Strong mechanism design skills

• Proficient in statistical methods / tools

• GD&T and Tolerance Analysis expertise

• Strong problem solver, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions

• Design controls expertise, experience with implementing product changes through a structured, phase-gated product development process

• Experience with design best practices, including design for reliability

• Working with regulatory standards

• Leadership and team building skills

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong design skills in mechanical mechanisms, electromechanical systems, pumps, micro motors, gears and assemblies including small fluidic systems or pumps

• Expert level with SolidWorks and use of GD&T, functional knowledge of advanced simulation and modeling techniques

• Established expertise in leading engineering analysis to predict behavior of proposed designs with analysis tools based on analytical or computational methods (e.g. GD&T, Tolerance Analysis, FEA, Minitab, Lab View)

• Solid understanding of IP considerations

• Knowledge of Design of Experiments (DOE), Design for Six Sigma (DFSS), Design for Manufacturing/Assembly (DFMA)

• Proficiency with data acquisition, analysis and statistical techniques using Labview, MatLab, Minitab etc.

• Familiarity with materials used in medical devices (best practices, biocompatibility)

• Demonstrated understanding of product development considerations for tightly controlled, high-volume manufacturing processes

• Clear understanding of product and process verification and validation including V&V, TMV, FAI, FAT/SAT IQ/OQ/PQ etc.

• Hands-on ability to work on test method development, fixture development, prototype assembly, preliminary concept generation testing/evaluation

• Broad and deep understanding of disciplined product development processes, regulatory, and quality requirements including design control. This includes understanding of phase gate process

• Demonstrated deep understanding of establishing project and product requirements

• Understanding and use of an innovation process utilizing elements of search, synthesis, and select

• Self-initiator, results driven and action & detail oriented

• Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams - both in writing and verbally

• Ability to manage competing simultaneous priorities effectively

• Ability to travel approximately 10-15% of the time, and international travel will be required

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.