Associate Director, Manufacturing Engineering & Industrialization

Our Mission

The mission of ISC Engineering is to seamlessly design and construct manufacturing processes that transform product specifications into industrialized solutions. Our goal is to serve patients and customers, enhance product reliability, and achieve business objectives more effectively through innovation and advanced technologies.

Position Summary

As a key leader within the Equipment Engineering Team, the Associate Director, ISC Engineering Design & Integration is a manufacturing process-oriented leader responsible for leading a defined equipment/process portfolio, platform, or multi-site scope across the BDI Segment. This role ensures assigned equipment assets and manufacturing processes are designed, supplied, integrated, ramped, and continuously improved in support of business growth, quality, cost, delivery, safety, and regulatory objectives.

The Associate Director contributes to segment-level strategy while driving execution, stakeholder alignment, technical excellence, and talent development across their assigned scope. This position leads a team of professional engineers and subject matter experts and serves as a critical link between R&D, ISC Engineering Process Design, Operations, Quality, Maintenance, and Production teams to successfully industrialize new products and modernize existing manufacturing processes.

This leader is expected to build organizational capability, develop future technical leaders, and demonstrate the strategic mindset, business acumen, and leadership presence required for future Director-level responsibilities.

Scope

• Provide leadership for new product development, capacity expansion, modernization, industrialization, and equipment reliability initiatives across manual, semi-automated, and fully automated manufacturing processes.
• Support the BDI network by prioritizing and executing improvement initiatives aligned with business objectives and strategic priorities.
• Own technical and people leadership outcomes for a defined portfolio, team, or multi-site program area, while influencing cross-functional teams, manufacturing sites, and external partners.

Key Stakeholders & Collaboration

This role partners closely with:

• Process Design Teams to ensure product designs support efficient, compliant, and scalable manufacturing through Design for Manufacturability (DFM) principles.
• Manufacturing & Operations Teams to ensure equipment capability, reliability, maintainability, and alignment to production requirements.
• Quality & Regulatory Teams to ensure compliance with all applicable quality and regulatory standards.
• Maintenance & Engineering Teams to maximize equipment reliability, lifecycle support, and troubleshooting effectiveness.
• Program & Project Management Teams to ensure successful project execution.
• Procurement, Finance & Legal Teams to support vendor selection, contracting, and capital expenditure governance.
• Suppliers & Equipment Vendors to oversee equipment design, build, acceptance, and integration.
• Facilities, EHS, and Digital/MES Teams to ensure infrastructure readiness, safety, ergonomics, and smart manufacturing capabilities.
• ISC Engineering Leadership to align priorities, manage resources, and support succession planning initiatives.

Key Responsibilities

Equipment & Process Strategy

• Develop and execute equipment and process strategies aligned with business needs and manufacturing objectives.
• Partner with Business Unit leaders and manufacturing stakeholders to understand demand, capacity constraints, growth opportunities, and supply requirements.
• Analyze operational performance data, including OEE/OLE metrics, to identify improvement opportunities.
• Build and maintain a multi-year technology and manufacturing roadmap that balances immediate priorities with long-term business growth.
• Support capital planning and long-range investment strategies.
• Translate strategic priorities into actionable execution plans, performance metrics, and resource requirements.

Portfolio Execution & Business Results

• Lead teams and cross-functional partners in delivering equipment and process improvement initiatives.
• Develop business cases, project charters, and resource plans for major investments and operational improvements.
• Collaborate with plant leadership to execute capacity expansion and performance improvement initiatives.
• Analyze manufacturing performance, failure trends, productivity losses, quality indicators, and maintenance data to drive improvements.
• Lead process characterization, validation activities, and manufacturing trials to verify technical feasibility and operational readiness.
• Provide industrialization guidance and knowledge transfer to manufacturing teams.
• Identify and resolve equipment, process, and workflow issues through sustainable corrective actions.
• Improve workplace safety, ergonomics, automation, and operator experience.
• Standardize engineering practices, technical standards, and sustainment processes.
• Ensure projects are delivered on time, within budget, and with measurable business impact.

Continuous Improvement & Standardization

• Capture and deploy best practices across manufacturing sites and business units.
• Develop and maintain equipment and process standards, databases, and specification templates.
• Support the creation of User Requirement Specifications (URS) and Statements of Work (SOW) for external vendors.
• Lead robust equipment design reviews with OEMs and suppliers to ensure long-term solutions address root causes and deliver sustainable performance improvements.
• Build organizational knowledge through lessons learned, technical playbooks, reusable standards, and scalable design practices.

Engineering Capability Development

• Identify capability gaps and partner with internal learning and development resources to strengthen technical expertise.
• Support employee growth through training, mentoring, coaching, job rotations, and stretch assignments.
• Serve as a technical leader and mentor within areas of expertise.
• Create opportunities for knowledge sharing and technical skill development.
• Develop future technical and people leaders through targeted coaching and professional development.

People Leadership

• Communicate clear priorities, expectations, and strategic objectives.
• Foster a collaborative, inclusive, and high-performing team culture.
• Drive accountability, engagement, and results through effective leadership.
• Directly manage and develop engineers, technical leaders, and SMEs through performance management, coaching, and career development planning.
• Build organizational capability and leadership bench strength through succession planning and talent development.
• Demonstrate strong business judgment, cross-functional influence, and enterprise leadership.

Qualifications

Minimum Education

• Bachelor's Degree in Engineering required.
• Mechanical Engineering degree preferred.
• Master's Degree in Engineering, MBA, or other advanced technical/business degree preferred.

Minimum Experience

• Broad-based business experience within a high-performance, multinational organization.
• 12+ years of experience in engineering, manufacturing, maintenance, automation, process development, advanced manufacturing, or related disciplines within medical device or other highly regulated industries.
• 5+ years of people leadership and/or technical team leadership experience, including coaching engineers and developing talent.
• Proven experience leading industrialization, equipment design and integration, automation, process improvement, and capital investment initiatives.
• Experience in manufacturing operations, maintenance and reliability, advanced manufacturing engineering, automation, and/or process design preferred.
• Demonstrated success leading technical initiatives across multiple sites, platforms, or functions.
• Strong ability to translate strategy into execution and influence stakeholders across the organization.
• Track record of driving change and delivering measurable business results.
• Excellent communication, collaboration, and leadership skills.
• Expertise in PFMEA, GD&T, tolerance stack analysis, SPC, process capability, equipment capability, validation, and qualification methodologies.
• Lean Six Sigma experience required; Black Belt certification preferred.

Additional Requirements

• Ability to travel up to 40-50%, depending on business needs and project activity.
• Must be legally authorized to work in the United States for any employer without current or future sponsorship requirements.