R&D Manager - Medical Device & Life Science

Responsibilities

• Represent the customer in order to ensure that the customer’s expectations are clearly understood and being met.
• Provide leadership to technical teams responsible for successful launch of multiple complex programs.
• Service and grow our program base within the Medical / Life Science Industry (Technical Sales).
• Oversee the coordination and on-time/in-budget completion of all projects which may involve some or all of the following: program management and measurement of machined product and fixtures/tooling, progressive stamped parts and tooling, insert molding parts and tooling, factory assembled automation, and other related tooling/processes.
• Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s.
• Ability to participate in product design (R&D) meetings with Medical Customers in relationship with Weiss-Aug Manufacturing technologies.
• Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities, monitor progress and report status to management/customer.
• Facilitate Tooling Kickoff, Specification Review, Design Review and Lessons Learned (Post Mortem) Meetings.
• Oversee the development and input of initial BOM and detailed Routing.
• Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation.
• Execute Engineering Studies on Existing and New Programs to facilitate and part optimization and debug.
• Create and define methods for simulation of assemblies to support “end of line” quality.
• Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation.
• Create and maintain process documentation. Train personnel as it relates to process documentation and procedures.
• Motivate and develop team members.
• Ability to understand top level asks, translate and set team direction to accomplish company goals.
• Jointly responsible for successful transfer of tooling to Manufacturing along with Toolroom and Design Engineering functions.
• Interface with outside suppliers to ensure they provide product or services on-time and to quality specifications.
• Absorb and manage program risks by considering tradeoffs between time, cost, customer needs and product and manufacturing physics.
• Support Sales and New Product Development Teams. May assist in identifying potential leads and opportunities.

Requirements

• Requires a 4-yr engineering, technical or management degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
• Minimum of 5 yrs. experience in program management/technical project management and/or manufacturing and/or product design (R&D) environment.
• Experience in medical device/life science industry required.
• Experience with product design, program/project management, and understanding of tight-tolerance manufactured products is required.
• Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning preferable.
• Knowledge of quality inspection tools and methods preferable.
• Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
• Knowledge of GMP/ISO Quality Systems required.
• Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.
• Knowledge of machined product, progressive metal stamping and/or insert molding processes desirable.
• Participate actively in a team-oriented environment. Provide leadership to cross-functional teams whenever necessary with ability to lead in all areas of a manufacturing organization.
• Ability to support Technical Sales and grow our program/customer base in the Medical Industry.
• Proficient in Microsoft Project. Able to create Gantt charts including: creation and linking of tasks, assigning of resources, tracking of tasks, and progress reporting.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Knowledge of Plex or MRP or ERP software preferable.
• Exceptional analytical and computational skills. Knowledge of problem-solving tools and techniques preferable.
• Excellent verbal and written communication skills.
• Demonstrated high level of negotiation and conflict-resolution skills.
• Demonstrated high level of creativity and innovation.
• Demonstrated decision-making capability.
• Demonstrated customer interfacing skills, including “soft skills” needed to facilitate technical sales.
• Must possess good analytical and problem-solving skills and mechanical aptitude.