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Program Manager, Medical Device Manufacturing

Location : Caldwell NJ US 07006
Job Type : Direct
Reference Code : 20355-AS1
Compensation : 90000.00 - 110000.00 USD/YEAR
Start Date : 11/02/2020
Hours : Full Time
Required Years of Experience : 10
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Engineering

Job Description :

  • Permanent position for a Medical Program Manager, Technical Lead working in a manufacturing and product design (R&D) environment.

  • Ensure that the customer's expectations are clearly understood and being met.

  • Direct teams across all organizational areas (Design, Engineering, Tooling, Quality, Manufacturing, and Sales).

  • Responsible for overseeing the coordination and on-time and on-budget completion of all project tasks for progressive stamping, insert molding, factory automation and other related tooling and processes.

  • Responsible for fostering a technical relationship with the customer to encourage additional sales through future product development areas, and facilitate the overall sales cycle.

  • Service and grow our technical sales within the Medical and Life Science Industry.

  • Responsible for Advanced Product Quality Planning (APQP) including completion of related documentation, including DOE's, FMEA's, Process Flowcharts, Control Plans, Capability Studies and Gage R&R's.

  • Participate in product design (R&D) meetings with Medical Customers in relationship with Company 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 and 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 coordination of the change control process (ECO) relating to Engineering documentation.

  • Oversee the selection and management of key suppliers as required by project.

  • Oversee the completion of requisitions for approval by management for purchased tooling or other product or services.

  • Interface with outside suppliers to ensure they provide product or services on-time and to specifications.

  • Manage program risks by considering tradeoffs between time, cost, customer needs and product and manufacturing physics.

Required Qualifications :

  • BS Engineering or Engineering Management

  • Minimum 10 years experience in manufacturing and / or product design (R&D) environment.

  • Experience in medical device/life science industry required.

  • Experience with product design, program and project management.

  • Understanding of tight-tolerance manufactured products is required.

  • Ability to read blueprints and other technical documents. Understanding of ANSI and ISO drawing standards and GD&T dimensioning preferable.

  • Ability to use SolidWorks for product and tooling design preferable.

  • Knowledge of quality inspection tools and methods preferable.

  • Familiarity with Statistical Process Control (SPC) tools and methods also preferable.

  • Knowledge of GMP and ISO Quality Systems required.

  • Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.

  • Knowledge of progressive metal stamping and / or insert molding processes desirable.

  • Ability to support Technical Sales and grow our customer base in the Medical Industry.

Contact: Alex Salewycz

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