Director of Operations
Henke Sass Wolf of America, Inc. is part of the global Henke Sass Wolf organization and operates in the medical device industry from our Dudley, Massachusetts location. We are committed to quality, continuous improvement, and delivering reliable solutions for our customers through a collaborative, hands-on work environment.
About the Role
The Director of Operations provides strategic and hands-on leadership for all Production and internal logistics functions at Henke Sass Wolf of America (HSWoA). The role is accountable for operational performance across Safety, Quality, Delivery, Cost, and People. As a member of the site leadership team, the Director of Operations drives sustainable performance through implementation of Just-in-Time principles (Takt, Flow, Pull, Zero Defects) and develops a high-accountability culture focused on execution and continuous improvement.
Responsibilities
- Own and deliver measurable improvements in throughput, on-time-delivery, turnaround-time and cost.
- Establish and sustain a daily management system with meaningful KPIs and accountability to implement countermeasures to stay on track.
- Lead structured problem-solving across functions; develop capability within the team.
- Align capacity planning, staffing and scheduling with customer demand.
- Standardize and continuously improve processes to ensure predictable performance.
- Drive implementation of flow-based/value-stream operations.
- Ensure operations comply with FDA QSR (21 CFR Part 820) and ISO 13485.
- Maintain training discipline, documentation accuracy, and audit readiness.
- Support the Quality Management Team during audits, inspections, and management reviews as the Operations representative.
- Lead, coach and develop Production Managers and Team Leaders.
- Foster ownership, urgency, transparency and cross-functional collaboration.
- Translate company strategy into clear operational priorities.
- Build a culture of accountability and continuous improvement.
- Develop leadership capability within the operations organization by mentoring managers and building succession strength for critical roles.
Key Performance Indicators
- Repair throughput (units/day)
- On-Time Delivery (OTD) and Turnaround Time (TAT)
- Direct labor productivity and material usage variance
- Warranty return rate
- Inventory accuracy and material availability
- Audit readiness and training compliance
- Employee engagement and leadership development
Qualifications
- Operations Management, Business, Engineering, or a related field, or equivalent progressive leadership experience in manufacturing or regulated production operations.
- Minimum five years of progressive experience in production or operations management within a regulated manufacturing or medical-device environment.
- Demonstrated success leading change.
- Strong analytical, problem-solving, and communication skills.
- Proven ability to manage multiple priorities and lead through change.
- Working knowledge of FDA QSR and ISO 13485 standards.
Preferred Skills
- 5+ years integrating new manufacturing lines, sites, or acquisitions.
- Lean/Kaizen experience.
Pay
Pay range: $150,000 – $210,000 annually. This range represents the amount we reasonably and in good faith expect to pay for this role. Final compensation may vary based on skills, experience, and other job-related factors. Incentive Compensation: Eligible for variable income bonus based on company and individual performance.
Physical & Work Environment Requirements
- Ability to stand/walk on production floor for extended periods; lift up to 25 lbs occasionally.
- Use of PPE and adherence to safety protocols.
- Work may occur in cleanroom or controlled environments depending on site.