Engineering Manager Medical Device

David C. Wojewoda

** ******** *****

Londonderry, NH 03053

*******@*******.*** Cell: 603-***-****

SUMMARY

An accomplished Program / Project and Engineering Manager having a strong business acumen and the ability to collaborate across organizational boundaries at all levels. Experienced in medical device and electro-mechanical R&D, Quality, Manufacturing, and Sustaining engineering, possessing a large breadth and depth of skills. Excellent analytics and problem-solving capabilities driven by data to optimize return on investment. Highly regarded by managers and peers for integrity and ability to generate effective solutions to complex problems. An accomplished team builder and mentor, encouraging a professional and energetic culture.

AREAS OF EXPERTISE

Project/Program Mgmnt (MS Proj, Daptiv, Workfront, Monday)

Manufacturing and Sustain Engineering Activities

Engineering Services (Equipment) Management

NPI/NPD, DHFs and Device Master Records (DMRs)

Quality Investigations (Exceptions, CAPAs, EFAs, OOTs)

Maximo, Windchill, Viewpoint, Agile, Infor, Arena

PROFESSIONAL EXPERIENCE

MEDTRONIC, Bedford / Billerica, MA 2023 – July 2024

Senior Engineering Manager - Manufacturing

Responsible for leading the cardiac ablation manufacturing engineering teams’ efforts to produce a highly advanced catheter for global markets. Multi – site responsibility managing and implementing all aspects of the initial design and development of new medical device products to market release.

Manages the growth of the organization to scale the business from acquisition to large scale manufacturing.

Provides day to day direction of the Engineering Manufacturing team (14 engineers and 7 technicians) to support commercial production in a 24 / 7 manufacturing environment.

ABBOTT LABORATORIES / St. JUDE MEDICAL, Westford, MA 2013 –2023

Senior Manager / Principal Project Manager, Abbott Vascular (AV) Division

Senior engineering and project / program manager involved with the manufacturing of 3-D cardiovascular imaging systems and specialized catheters for world-wide distribution. Tasks include leading cross functional teams’ efforts to meet business strategic goals within an FDA 21CFR820/ ISO 13485 environment.

Program Management

Directed cross functional teams’ efforts to ensure all products (and components) are RoHS compliant. An intense ten (10) month effort encompassing design changes from the PCB level through system configuration. Responsible for DHF and DMR completions.

Scaled Design Development Plan’s (SDDP) for a PC replacement. Directed life cycle management from concept to commercialization.

Remote cardiac monitoring system with embedded software; program management from development to release authorization. Utilized Earned Value (EV) Project Management techniques combined with event charts to present the health of the project to stakeholders.

Project Management

Lead a team of 20+ engineers (10+ off-shore) to remediate equipment non-conformances identified during an FDA audit. Updated the product data management system documentation to align with that of the Computerized Maintenance Management System for 3000+ assets.

Successful 11-month CAPA resolution prompted by field failures. DMAIC principles utilized while working with R&D, Quality and Ops to develop, test, validate and implement proprietary material.

David C. Wojewoda Page Two

Directed a six (6) person team’s efforts to ensure adequate process controls are in place to provide zero defects of all manufactured products.

Lead efforts to increase catheter production yields.

Directed three (3) teams to reduce the facility’s Non-Conforming Material Review (NCMR) rate.

Lead efforts to reduce the Material Review Board’s (MRB’s) inventory by greater than 50%. Initiated a focused “Knockout Week” to close a record number of NCMRs and dramatically reduce inventory. Successfully completed the project 4-months ahead of schedule.

Engineering Services (Equipment) Management

Directed a Calibration and Preventative Maintenance team of ten (10) to service greater than 3500 assets allowing for 7-day, 2-shift production operation utilizing a Maximo Computer Maintenance Management System (CMMS) database. Metrics regularly collected / reported to senior management.

MOTOROLA MOBILITY (GOOGLE), Lowell and Marlborough, MA 2006 – 2012

Principal Hardware Engineer/Manager, Electro-Mechanical Sustain Engineering 2011 – 2012

Lead engineer/manager responsible for multi-site hardware development and sustaining efforts for high volume, electro-mechanical devices. Directs customer service issues, focusing on quality enhancements. Program management of third-party product development teams. Complete product life cycle accountability.

Program manager of New Product Development (NPD) projects ($200K to $1+M).

Managed EFA (Engineering Failure Analysis) efforts. Direct customer interfacing. As a certified six sigma Green Belt, used DMAIC methods to determine and resolve root causes.

EMS (Electronic Manufacturing Services) interface with factory personnel in China to resolve issues related to the product and process. MOL (Maintenance of line) responsibility for high volume.

Supplier and component qualifications.

Responsible for establishing high volume manuf. transfer to China.

Compliance Manager 2010-2011

Coordinated and performed testing at ITLs. Testing to meet NEBS, Verizon, UL, CSA, CE and FCC specifications. Expenses exceeding $500K annually.

Senior Staff Engineer/Manager, Electro-Mechanical Hardware Sustain Engineering 2006 – 2010

Collaborate with engineering teams in Taiwan, China, India and US locations to resolve vital issues.

Mechanical engineer responsible for the transition of entire engineering support team from CA to MA.

RAYTHEON, Tewksbury, MA

Senior Systems Engineer, Mission Effectiveness (Integrated Defense Systems)

LUCENT TECHNOLOGIES / BELL LABORATORIES, North Andover, MA

Physical Design Senior Engineer; Bell Laboratories

Manufacturing/Process/Product Engineer (Senior/Lead)

Mechanical Machine Design Engineer, OEM Manufacturing Equipment

EDUCATION

BS, Mechanical Engineering, University of Massachusetts, Amherst, MA

Bioengineering Master’s Degree Program, Tufts University, Medford, MA

AWARDS AND PATENTS

Holder of three (3) United States Patents

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