Equipment Engineering Manager

Job Description

The position holder is responsible for the operations equipment engineering for Single Use Endoscope (SUE) products. Promote proactive equipment standardization and development across all SUE Product lines throughout the product development phases. 

The position holder leads a team of engineers to develop and improves equipment requirements, designs, and specifications inclusive of mechanical, electrical hardware, and control systems as needed according to product delivery requirements to deliver equipment solutions which have overall equipment effectiveness that enables efficient and effective manufacturing.

 Partners with internal and external partners to ensure effective build, qualifications, and release of equipment

Job Duties

• Direct supervisory responsibility for, Engineers, Technicians and contract staff.
• Provide mentorship, coaching and career growth opportunities to the engineering team.
• Develop and manage project budgets and resource plans across the team, applying agile techniques to re-balance when necessary to meet the business objectives.
• Establish plans and complete product and test equipment and fixturing activities to meet project goals including specification development, design reviews, prototype development, qualification/acceptance testing, and release.
• Ensure outstanding capability through the product development processes including FDA compliance and alignment to the phase gate product development process.
• Develop and deliver project status reports, proactively identifying, resolving, and presenting any issues that may impact the team’s ability to meet key goals.
• Liaison with leaders in process engineering, industrial engineering, and cross functional partners to ensure that equipment solutions are integrated effectively into the overall manufacturing process architecture.
• Develop skill sets of assigned staff to meet functional objectives, business objectives and employees' professional goals.
• Coordinate with leadership colleagues across various functions to foresee/understand critical project activities and to enable them to manage team resources and tasks to avoid critical path slippage.
• Evaluate all available internal and external Operational SUE Product launches including manufacturing equipment, and capabilities.
• Partner with process and industrial engineering to select and implement appropriate technologies that result in lower manufacturing cost, lower process variability and higher manufacturing capability and reliability.
• Prioritizes and manages execution of work within the team of direct reports.
• Works with other leaders cross-functionally to standardize, leverage and implement engineering tools and establish best-demonstrated practices.
• Provides engineering resources in support all necessary projects and activities.
• Own and drive all operations and equipment safety and risk management documentation.
• Drive proactive behavior within the engineering team.
• All Other Essential Duties as directed.

Job Qualifications

Required:

• B.S. degree in Engineering or equivalent.
• An advanced degree (M.S. or MBA.) in any of these fields is preferred.
• Minimum 10 years of industry experience with a proven track record of successful equipment development within a regulated environment; medical device experience.
• Minimum 3 years of management experience with multiple direct reports.
• Ability to travel up to 25% mostly Domestic required.

Preferred:

• Exceptions to the criteria may be allowed for candidates that meet combinations of criteria or have additional exceptional skill sets.
• Experience working in a multidisciplinary team setting bringing new equipment from conception through and beyond. 
• Demonstrated ability of delivering effective and reliable equipment from an overall equipment effectiveness perspective.
• Expertise with the development of complex and precision mechanical or opto-mechanical test equipment.
• Experience in test method and equipment qualification.
• Strong documentation abilities to clearly and thoroughly document requirements, specifications, and test protocols.
• Experience partnering with both internal and external partners for the development of new equipment technologies.
• Good team leader and manager, wide technical knowledge base, with above average problem analysis skills
• Able to think both logically and creatively and possess sound reporting abilities
• Strong knowledge of core engineering tools. For example: Mechanical design, electrical schematics, OEE, Risk Analysis, process mapping, programming and logic.