Engineering Senior Manager

The Engineering Senior Manager provides strategic engineering leadership across four core functional areas: Program Management, Manufacturing Engineering, Process Development, and Operational Excellence. This leader is responsible for building and executing engineering strategies that advance process capability, accelerate new product introduction (NPI), and develop a high-performing technical talent pipeline in a regulated medical device environment.

The ideal candidate brings deep hands-on expertise in injection molding, extrusion, and electronics/electromechanical systems, combined with a strong command of quality systems and regulatory requirements applicable to sterile-use medical devices including catheters and fluid delivery systems. This role operates in a fast-paced, globally integrated environment and demands a leader who is equally effective on the manufacturing floor and as well as in leadership forums.

Program Management

•       Lead and govern cross-functional engineering programs through commercial launch, ensuring on-time, on-budget, and on-quality delivery.

•       Establish and maintain program governance frameworks, milestone reviews, risk registers, and escalation pathways.

•       Coordinate engineering resources across internal teams and external development partners, and suppliers.

•       Partner with quality and R&D to ensure all programs meet applicable regulatory requirements (FDA 21 CFR Part 820, ISO 13485, MDR, etc.).

•       Report program status and engineering KPIs to senior leadership on a regular cadence.

Manufacturing Engineering

•       Provide technical oversight and strategic direction for all manufacturing engineering activities supporting electromechanical and single-use sterile medical devices including catheters and fluid delivery systems.

•       Drive process validation (IQ/OQ/PQ), equipment qualification, and process control strategies in accordance with design control and GMP requirements.

•       Lead engineering input into facility layout, capital equipment planning, and manufacturing capacity strategy.

•       Ensure manufacturing processes are repeatable, scalable, and compliant with applicable standards.

•       Own technology transfer from development to full-scale manufacturing, including documentation, training, and capability demonstration.

Process Development

•       Develop and optimize core manufacturing processes with emphasis on:

• Injection molding (thermoplastics, LSR, insert molding, overmolding)
• Extrusion (catheter tubing, multi-lumen, co-extrusion)
• Electronics assembly and electromechanical integration
• Catheter assembly, tip forming, bonding, and sterile barrier systems
• Fluid delivery system assembly and testing

•       Apply statistical methods (DOE, SPC, Cpk/Ppk analysis, FMEA) to develop robust, capable processes.

•       Lead process capability development initiatives that systematically reduce variation and improve yield.

•       Collaborate with R&D and Product Development to ensure designs are optimized for manufacturability (DFM/DFA).

•       Maintain current knowledge of emerging process technologies and drive appropriate adoption.

Operational Excellence

•       Champion a culture of continuous improvement using Lean, Six Sigma, and related methodologies across the engineering organization.

•       Define and track operational metrics (OEE, yield, cycle time, COPQ, scrap rates) and drive performance improvement initiatives.

•       Lead kaizen events, value stream mapping, and root cause/corrective action (CAPA) efforts.

•       Partner with Quality and Operations to build a sustainable quality management system aligned with ISO 13485 and FDA QSR requirements.

•       Identify and eliminate waste across engineering and manufacturing workflows to improve cost and throughput.

Engineering Strategy & Leadership

•       Develop and execute a multi-year engineering strategy aligned with business objectives, product roadmap, and operational goals.

•       Build and lead a high-performing engineering team; recruit, develop, and retain top technical talent.

•       Establish a technical talent pipeline through structured development programs, mentorship, and succession planning.

•       Define career paths and competency frameworks for engineering roles across the function.

•       Foster a culture of engineering excellence, accountability, innovation, and cross-functional collaboration.

•       Represent the engineering function in executive reviews, customer audits, and regulatory inspections.

•       Manage departmental budgets, headcount planning, and capital expenditure forecasting.

Education

•       Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a closely related engineering discipline required.

•       Master's degree (MBA or MS in Engineering or related field) preferred.

Experience

•       Minimum 10+ years of progressive engineering experience in a regulated manufacturing environment, with at least 4 years in an engineering management or senior leadership role.

•       Demonstrated expertise in injection molding processes (thermoplastics, LSR, insert molding) required.

•       Demonstrated expertise in extrusion processes (catheter tubing, multi-lumen extrusion) required.

•       Hands-on experience with electronics manufacturing and electromechanical device assembly required.

•       Proven track record leading NPI programs from development through commercial launch in a regulated environment.

•       Experience building engineering capability and talent pipelines in a growth-stage or scaling organization.

Technical Skills

•       Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable IEC standards.

•       Proficiency in process validation methodologies (IQ/OQ/PQ) and design control (21 CFR 820.30).

•       Applied experience with statistical tools: DOE, SPC, FMEA, GR&R, Cpk/Ppk analysis.

•       Lean / Six Sigma expertise; Green Belt or Black Belt certification preferred.

•       Familiarity with ERP and MES systems; PLM experience a plus.

•       Experience with automated assembly systems and vision inspection integration.

Leadership & Competencies

•       Exceptional leadership presence with the ability to influence without authority across functions and geographies.

•       Strong strategic thinking with the ability to translate vision into executable engineering roadmaps.

•       Excellent communication skills — written and verbal — with the ability to present to executive leadership, customers, and regulatory bodies.

•       Demonstrated ability to manage multiple priorities in a fast-paced, deadline-driven environment.

•       Collaborative, team-oriented mindset with a bias toward action and accountability.

•       Ability and willingness to travel globally as required (estimated up to 30%; higher during ramp-up phases).

PREFERRED QUALIFICATIONS

•       Experience with intravascular or interventional device manufacturing (catheters, guidewires, sheaths, stents, balloon systems).

•       Exposure to CE Marking, MDR/IVDR, or other international regulatory pathways.

•       Experience leading engineering operations across multiple global sites.

•       Prior P&L or cost center management responsibility.

•       Six Sigma Black Belt or Lean Master certification.

WORK ENVIRONMENT & PHYSICAL REQUIREMENTS

•       Work is performed in a combination of office and cleanroom/manufacturing environments.

•       May be required to wear gowning, PPE, or other cleanroom attire when on the manufacturing floor.

•       Global travel required, including international travel to manufacturing sites, suppliers, and customer locations.

•       Ability to stand, walk, and be present on the production floor for extended periods.