Senior Manufacturing Engineer

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Plans and designs manufacturing processes as well as design methods to support medical device component manufacturing and improve efficiency in production. This position supports operation’s goals by analyzing and managing change of existing processes, machining steps, product related drawings, specifications, standards, and tooling required in the manufacture of components. Duties will include documenting existing systems and equipment functions, writing and performing testing of equipment to perform its intended functions, and working with senior staff of technicians, machinists, and management to document existing methods and tools.

This position acts as the subject matter expert (SME) for assigned product lines which includes supporting audit activities and first response for shop floor alerts.

• Works with Harmonic materials for the manufacture of medical devices. Knowledge of machining and ability to analyze data and draw cause and effect conclusions is part of responsibilities. Learn the product mix and machining steps and build institutional knowledge.
• Designs and works with other engineering personnel to create and develop engineering prototypes of new products/processes.
• Executes tactical implementation of strategic plans.
• Prepares cost and time estimates for engineering and project schedules.
• Instructs engineers and technical support staff on engineering test and build requirements.
• Works as a team leader (and as a team member when required) in the development of engineering designs and tests.
• Writes engineering test protocols for testing of component parts and integrated systems.
• Develops and writes specifications for components/systems, product, processes and packaging/labeling.
• Authors various type of qualification protocols and reports (IQ/OQ/PQ) and PV.
• Works with engineering personnel on production problems and changes as necessary.
• Works with RA/QA and Documentation departments to establish proper regulatory and quality documentation procedures.
• Works with Marketing and cross-functional teams to define and introduce new products.
• Works directly with finish goods suppliers in all aspects of product/process development, release and sustaining activities.
• Leads and implements projects for transfers, new product introductions and Cap Ex spend.

• Education & Experience:
  • BS degree in Mechanical Engineering or Equivalent discipline with at least eight (8) years of related engineering experience; or MS in relevant discipline with at least five (5) years of related engineering experience.
  • Ability to effectively solve complex problems and ability to influence and communicate across all functional groups and levels.
  • Excellent verbal and written communication skills.
  • Medical device experience is desired.
  • Proficiency with development tools (e.g. Solid Works, autocad) used by the department.
  • Knowledge of Engineering Change Order System.
  • Knowledge of engineering test protocols.
  • Ability to lead teams through complex projects.
  • Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PQ qualifications as related to medical devices is required.
  • Ability to make presentations at company meetings.
  • Ability to communicate effectively with internal and external personnel.
  • Ability to provide departmental technical leadership.
  • Ability to review and analyze engineering reports.

• Ability to utilize a telephone, fax, copier and desktop computer with finance and other typical business programs installed, including spreadsheets, word processing and MRP/ERP systems. Strong computer skills are required. Knowledge and experience with MRP/ERP systems is required.

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the…