Production Manager

Kirkstall Precision; Indiana (PA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

High-impact leadership role

Collaborative culture

Life-changing medical devices

Job summary

Kirkstall Precision in the United States seeks a hands-on Production Manager to lead daily manufacturing operations in a regulated medical device environment, embedding safety, quality, and efficient production. You will work with the OpEx Manager to establish governance and drive stabilization during the transition.

The role emphasizes building capability, leading teams, improving KPIs, maintaining equipment, and ensuring audit readiness with ISO 13485 and GMP compliance, while shaping S&OP and

Qualifications

• 5+ years in manufacturing or operations leadership in regulated sectors.
• Strong knowledge of ISO 13485, GMP, or similar regulated environments.
• Proven track record in team leadership, performance management, and CI.
• Experience with Lean, 5S, Kaizen, Root Cause Analysis and continuous improvement.
• Strong planning, organizational, and communication skills.
• Engineering/Manufacturing or Operations degree preferred.

Responsibilities

• Lead daily manufacturing performance with targets for quality, cost, delivery, and safety.
• Ensure compliance with ISO 13485, GMP and internal QMS.
• Monitor and improve KPIs (output, yield, scrap, setup time, labor utilization).
• Maintain calibration and fit-for-purpose equipment, tooling, and fixtures.
• Co-lead governance with OpEx, including Tier meetings and action tracking.
• Embed Standard Work and ensure consistent application through Team Leaders.
• Lead continuous improvement using Lean, 5S, Kaizen, SMED and structured problem-solving.
• Support NCR, CAPA and deviation investigations with corrective actions.
• Partner with Planning, Supply Chain, Engineering, NPI and Quality for scheduling and material availability.
• Input into S&OP process and identify risks to output.
• Provide clear, timely reporting on performance, risks, and trends.
• Ensure production activities are audit-ready and well-documented.

Skills

Leadership in manufacturing

Lean Manufacturing

Planning & communication

Education

Engineering/Operations degree

Job description

Medical Device Precision Engineering (Orthopaedic Instruments & Implants)

We are seeking a hands-on Production Manager to lead day-to-day manufacturing operations in a growing, regulated medical device environment. The role is accountable for safe, compliant, and efficient production while embedding operational discipline, developing team capability, and driving continuous improvement.

Operating in a period of transition and growth, this role suits a leader comfortable with ambiguity and building standards where they do not yet exist. The Production Manager will work closely with the OpEx Manager to embed governance, Tier accountability, problem-solving, and visual management, and will play a key role in stabilising operations as the current Production Director transitions into an NPI-focused role.

Electric discharge machining department at Kirkstall Precision

Key Responsibilities

Leadership & Capability

• Build a safety-first, quality-focused culture with clear accountability and strong teamwork.


• Lead, coach, and develop Team Leaders and production teams in daily management, problem-solving, and people leadership.


• Set daily and weekly priorities, allocate resources, and support workforce training and development.


• Contribute to S&OP and longer-term capacity, staffing, and investment planning.

Production Operations

• Own daily manufacturing performance, ensuring targets for quality, cost, delivery, and safety are met.


• Ensure compliance with ISO 13485, GMP, and internal QMS requirements.


• Monitor and improve key production KPIs (output, yield, scrap, setup time, labour utilisation).


• Ensure equipment, tooling, and fixtures are maintained, calibrated, and fit for purpose.

Operational Excellence & Improvement

• Co-lead operational governance with OpEx, including Tier meetings, escalation, and action tracking.


• Embed Standard Work and ensure consistent application through Team Leaders.


• Lead continuous improvement using Lean, 5S, Kaizen, SMED, and structured problem-solving.


• Support NCR, CAPA, and deviation investigations with robust, data-driven corrective actions.

Planning & Coordination

• Partner with Planning, Supply Chain, Engineering, NPI, and Quality to ensure effective scheduling, material, and tool availability.


• Input into the S&OP process


• Identify and mitigate risks to output (capacity, materials, equipment, staffing).


• Provide clear, timely reporting on performance, risks, and trends.

Compliance & Audit Readiness

• Ensure production activities are fully documented and audit-ready at all times.


• Support internal, customer, and regulatory audits.


• Approve manufacturing documentation, including batch records, work instructions, and change controls.

Skills & Experience

• 5+ years’ experience in manufacturing or operations leadership, ideally in medical devices, precision engineering, aerospace, food, FMCG or another regulated sector.


• Strong knowledge of ISO 13485, GMP, or regulated manufacturing environments.


• Proven track record in team leadership, operational improvement, and performance management.


• Experience with Lean Manufacturing, 5S, Kaizen, Root Cause Analysis, and CI methodologies.


• Strong planning, organisational, and communication skills.


• Engineering, Manufacturing, or Operations degree (or equivalent experience) preferred..

What We Offer

• A high-impact leadership role in a growing medical device business.


• A collaborative, improvement-driven culture.


• The opportunity to contribute directly to the manufacture of life-changing medical devices..

Hours

7am – 3:30pm (2:30pm on Fridays). Occasional evening shift, and weekend overtime cover may be necessary.

Contract

12-month Fixed Term