Senior Engineering Manager

1 month ago

Saint Michael, United States Talencio Full time

Senior Engineering Manager of Product Design/Manufacturing


Company Overview:

Our client is a leading innovator in the medical device sector, specializing in unique surgical solutions. With its revolutionary technology, the company is redefining medical innovation boundaries.

Are you an Engineering Leader with a passion for groundbreaking solutions and a desire to be part of charting new territory?

If so, we’d love to connect.


Position Overview

This is a player/coach role, providing technical leadership for product design and manufacturing teams. Take concepts from R&D and implement functional, manufacturable, cost-effective product designs and associated manufacturing processes. Lead product design and manufacturing teams to successfully transition new products into manufacturing, consistent with medical product regulatory standards and Good Manufacturing Practices.


Work closely with the R&D team to support product concept development and prototype builds. Work closely with the Quality team to ensure all product, process, training, and qualification documentation is complete and compliant with regulatory requirements. Work closely with the Operations team to support the build schedule and implement product and process improvements. Work closely with the Finance/Accounting team to support business system implementation and achieve COGS targets. Provide technical and organizational leadership for the PD and manufacturing technical team.


PRIMARY RESPONSIBILITIES

  • Provide technical leadership for product design and manufacturing engineering activities.
  • Work both independently and in cross-functional teams developing, troubleshooting, and standardizing the design, manufacture, and test methods for novel products including the improvement of existing test methods and procedures.
  • Lead product and process improvement projects, including engineering change management, product cost reduction, manufacturing process improvement, tool/fixture development, equipment sourcing and implementation, PM, training, etc.
  • Define and implement processes, systems, and documentation needed to produce products, including:
  • CAD software, traditional and additive manufacturing technologies, and good engineering drawing practices to design, build, and document test and manufacturing processes, tooling, and fixturing.
  • Manufacturing processes, routers, specifications, inspection procedures, etc. for manufacturing according to GMP, ISO, and FDA requirements.
  • Maintenance of all equipment, tooling, and fixtures used in manufacturing.
  • Packaging and sterilization operations.
  • Lead production activities during pilot production phases, including:
  • Batch builds for prototypes, testing, clinical studies, and early sales.
  • New supplier identification, evaluation, and qualification.
  • Verification and validation testing.
  • Supplier orders and inventory management.
  • Production scheduling and execution.
  • Work closely with R&D, Operations and Quality on all projects and day-to-day activities.


QUALIFICATIONS, EDUCATION & EXPERIENCE

  • Bachelor’s degree in relevant engineering disciplines (mechanical, manufacturing systems, etc.).
  • 8-10 years’ experience in transitioning new products from R&D to manufacturing.
  • 8-10 years’ experience in the medical devices/products industry
  • 5 or more years leading teams with direct people management responsibilities (>2 direct reports).
  • SolidWorks® CAD experience.
  • Experience in using sound engineering judgment and analytical skills to conduct root cause analysis to solve engineering problems.


KNOWLEDGE, SKILLS, AND ABILITIES

  • Strong verbal and written communication skills with the ability to communicate ideas to all levels of the organization.
  • Ability to work in office, lab, and production floor environments.

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