JOB DESCRIPTION  

Our Client is searching for a Sr. Manager, R&D – Mechanical Engineering to lead a team focused on product development of large complex new-to-world product development platforms that help people with diabetes live healthier lives. The successful candidate will be responsible for leading the Mechanical Engineering team for the development of disposable electromechanical infusion devices to enable solutions for chronic disease management and other wearable applications. We are recruiting for a highly driven technical manager with a passion for problem-solving and a proven track record of successfully developing medical products. The Sr. Manager will report to the Director of Innovation and New Product Development. The ideal candidate will also 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 Design Control 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 capable design and development

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

• Provide necessary supporting data for regulatory submissions for product approval

• 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 pump systems.

• 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

Desired Qualifications:

• Graduate degree (MS or PhD) in Mechanical Engineering or related field

• 10+ years of post-educational experience in Medical Device Design highly desired

• Experience as lead in the development of medical disposable devices highly desired

• Pharmaceutical Infusion pump development experience

• Proficiency with statistical techniques including familiarity with Gage R&R, Reliability, analysis of variance (ANOVA) and design of experiment (DOE) methodologies

• Expertise in common risk management techniques

• Experience in electromechanical drug delivery or drug combination devices

• Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired

Knowledge, Skills and Abilities:

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

• Experience designing 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

• Proficiency in Microsoft Project or equivalent project planning software

• 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 25% of the time, and international travel will be required.