Summary of Major Responsibilities
The Manager, Sustaining Engineering will lead a team of technical professionals to ensure product support exists for installed base products of Exact Sciences instrument as well as be the thought leader in instrument production and services. This role will ensure that Exact Sciences instrument performance specifications can be maintained throughout the product lifecycle. The Manager, Sustaining Engineering, actively participates on Research/Development and System Engineering project teams to ensure instrument production and serviceability is fulfilled.
Essential Duties and Responsibilities
- Champions the ECO (engineering change order) and NPI (new product introduction) processes and implementation of engineering records.
- Manages compliance activities such as CE marking, ROHS, CSA, and compliance documentation for medical device product lines.
- Manages root cause analysis for production failures.
- Responds to requests for support from Exact Sciences Laboratories, Technical Services, and Manufacturing Operations groups needing technical analysis.
- Provides oversight of key production tools. Drives process and facilities continuous improvement activities.
- Prioritizes dynamic project lists and coordinates team resources to ensure timely execution of engineering projects. Works with other functional leaders to ensure alignment on resourcing.
- Assures engineering team adherence to company processes and procedures.
- Assures completeness and quality of work of sustaining engineering and the instrument production team.
- Drives a team culture by closely partnering with systems engineers, manufacturing operations, quality, supply chain, project management and product management.
- Actively participates in engineering projects as a working manager when and where required.
- Provides weekly/monthly/quarterly/annual updates to various levels of leadership on the department’s progress toward various objectives.
- Identifies training needs of team and its members and participates in the training to build skills and improve performance.
- Communicates effectively with all levels in the organization, ability to communicate cross functionally.
- Participates in the development and/or improvement of company procedures that are associated with the engineering function through frequent R&D or process improvement meetings.
- Assists in generating and maintaining expense and capital budgets for department.
- Leads a team of talented sustaining engineers.
- Develops company engineering policies and procedures.
- Practices design for manufacturability and assembly (DMFA) and lean manufacturing principles.
- Supports and complies with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work normal schedule of Monday through Friday during normal business hours.
- Ability to lift up to 45 pounds for approximately 5% of a typical working day.
- Ability to work seated for approximately 90% of a typical working day. Ability to work standing for approximately 10% of a typical working day.
- Ability to work in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to travel approximately 15% of working time.
- Bachelor’s Degree in Engineering or a related field.
- 7+ years of manufacturing and engineering design experience in medical device field.
- 2+ years of technical personnel mentorship/leadership experiences.
- Authorization to work in the United States without sponsorship.
- Proficiency in engineering tools/processes – PPAP, DVP&R, DFMEA, PFMEA, DFMA, ECO, ERP systems, BOM structures.
- Proficiency in MS Word, Excel, Power Point, Project and Outlook.
- Proficiency with process and industrial automation equipment and requirements.
- Proficiency in sheet metal part design and material selection – stamping, forming, drawing and spinning.
- Understanding of instrumentation products, mechanics and electronics.
- Regulatory agency experience/knowledge (UL, CSA, CE, ROHS).
- Experience in developing company engineering policies and procedures.
- Understanding/practice Design for Manufacturability & Assembly (DFMA) and Lean Manufacturing principles preferred.