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.