Operations Manager -Medical Device

Job Title: Operations Manager

Location: Torrington CT

Fulltime Permanent role

Job Description:

We are seeking a strategic, customer-focused Operations Leader to lead and optimize our manufacturing operations. This role is responsible for end-to-end plant execution, including Production, Manufacturing Engineering, Quality, and Maintenance.

As a key member of the Senior Leadership Team, this individual will contribute to business strategy, budgeting, and operational planning, while driving daily execution and performance.

The ideal candidate brings a strong foundation in engineering and quality, along with proven experience in regulated manufacturing environments. This leader will play a critical role in New Product Introduction (NPI), validation, and transfer of business, including the launch of new products and integration of equipment and processes from sister sites.

This individual is a highly collaborative and people-focused leader, capable of engaging with customers, aligning cross-functional teams, and building a strong, accountable culture.

Key Responsibilities

Strategic & Leadership Team Contribution

Serve as a key member of the Senior Leadership Team, contributing to:

Business strategy and long-term planning

Annual operating plans and goal deployment

Organizational design and capability building

Provide leadership in budget development, cost management, and operational forecasting

Demonstrate strong P&L awareness, aligning operational decisions with financial performance

Operational Leadership

Lead plant operations across Safety, Quality, Delivery, Cost, and People (SQDCP)

Drive execution through structured daily management systems and KPIs

Build a culture of accountability, collaboration, and continuous improvement

Ensure alignment between operational performance and customer expectations

Customer Engagement & Cross-Functional Collaboration

Act as a key operations-facing leader for customers, supporting:

Business reviews, technical discussions, and site visits

Escalations and issue resolution

Partner closely with Customer Service and Planning to:

Align demand, capacity, and production schedules

Communicate risks and ensure delivery commitments

Collaborate with Program Managers, Engineering, and Quality to ensure seamless execution

Production & Manufacturing Execution

Lead production through Production Managers and Shift Supervisors

Ensure delivery of production targets with focus on efficiency, throughput, and schedule attainment

Optimize performance in a high-volume, labor-intensive environment

Drive improvements in OEE, capacity, and operational flow.

Engineering, NPI & Validation

Lead Manufacturing Engineering and provide strong technical leadership to operations

Partner with NPI teams and Program Managers to:

Support product development and transfer into manufacturing

Ensure Design for Manufacturability (DFM)

Execute and sustain process validation (IQ/OQ/PQ)

Ensure successful launch of new products and processes, meeting quality, cost, and delivery expectations

Transfer of Business & Capacity Expansion

Lead and support transfer of products, processes, and equipment from sister sites

Oversee installation, qualification, and ramp-up of new machines and technologies

Ensure smooth transitions with minimal disruption to customer delivery and quality performance

Align resources, training, and process readiness to support capacity expansion

Quality & Regulatory Compliance

Ensure compliance with ISO 13485 and applicable medical device regulations

Partner with Quality to:

Drive effective CAPA and root cause analysis

Reduce defects, scrap, and customer complaints

Maintain audit readiness and successful inspections

Promote a proactive quality culture across operations

Maintenance & Equipment Reliability

Oversee preventive and predictive maintenance programs

Ensure high levels of equipment uptime and reliability

Drive improvements in downtime reduction and asset utilization

Support capital investment planning and execution

Continuous Improvement

Lead Lean and Six Sigma initiatives across the plant

Drive measurable improvements in:

Throughput and cycle time

Cost reduction

Waste elimination

Establish a culture of structured problem-solving and operational excellence

People Leadership & Culture

Lead, coach, and develop teams including:

Production leadership

Manufacturing Engineering

Maintenance leadership

Build a people-first, high-performance culture focused on:

Engagement and accountability

Leadership development and succession planning

Partner with HR to strengthen organizational capability and culture

Financial & Operational Performance

Develop and manage plant budgets and cost performance

Drive cost improvement initiatives and operational efficiency

Utilize KPIs and data analytics to support business decision-making

Align operational execution with financial goals and performance targets

Qualifications

Bachelor's degree in Engineering

Advanced degree (MBA or MS) is a plus

10 years of leadership experience in manufacturing operations

Proven experience leading multi-functional teams (Production, Engineering, Quality, Maintenance)

Strong experience with:

New Product Introduction (NPI)

Process validation (IQ/OQ/PQ)

Transfer of business and equipment between sites

Experience in medical device manufacturing strongly preferred

Injection molding experience preferred

Technical & Leadership Skills

Strong expertise in:

Manufacturing Engineering and process development

Validation methodologies

Quality systems and regulatory compliance

Deep understanding of ISO 13485

Experience with Lean Manufacturing / Six Sigma

Strong financial acumen with P&L awareness

Excellent communication skills with the ability to engage customers and internal stakeholders

Strategic & Financial Acumen

Technical & Operational Leadership

NPI & Product Launch Execution