Sr. Mgr, Engineering Manager

TEI BIOSCIENCES INC; Braintree (MA); On-site; USD 125,000 - 173,000; Full time

Job summary

Integra LifeSciences is seeking a Senior Manager, Engineering Manager to lead engineering, facilities, maintenance, and utilities for manufacturing operations. You will ensure compliance with FDA/ISO standards and drive continuous improvement in asset management and infrastructure.

In this role, you will collaborate with Operations, Quality, and Supply Chain, manage budgets, and direct contractors to deliver safe, compliant, and efficient facilities performance across sites.

Qualifications

• Bachelor's degree with a minimum of 8 years of relevant engineering, facilities, maintenance, or EHS experience.
• Minimum of 3 years of leadership experience in a regulated manufacturing environment.
• Experience in medical device, biologics, tissue technologies, pharmaceuticals, or other FDA-regulated industries preferred.

Responsibilities

• Lead engineering, facilities, maintenance, and utility operations to support manufacturing and business objectives.
• Ensure facilities, equipment, utilities, and infrastructure are maintained in compliance with applicable regulatory, safety, and quality requirements.
• Develop and implement preventive maintenance, calibration, reliability, and asset management programs.
• Manage engineering projects, facility modifications, equipment installations, utility upgrades, and capital improvement initiatives.
• Provide technical leadership for equipment qualification, facility validation, process improvements, and continuous improvement activities.
• Support manufacturing operations by identifying and resolving equipment, facilities, and process-related issues.
• Develop departmental budgets, capital expenditure plans, and resource forecasts.
• Manage contractors, vendors, and service providers to ensure work is completed safely, efficiently, and in compliance with company requirements.
• Coordinate facility inspections, repairs, maintenance activities, and utility monitoring programs.
• Ensure adequate capacity planning and infrastructure support for current and future business needs.
• Maintain facility drawings, engineering documentation, equipment records, and maintenance history files.

Skills

Leadership

Regulatory compliance

Facilities management

EHS awareness

Education

Bachelor's degree with 8+ years in engineering/facilities/EHS

Tools

SAP

CRM platforms

MS Project

Jira

QMS platforms

Job description

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Senior Manager, Engineering Manager is responsible for the leadership, management, and continuous improvement of engineering, facilities, maintenance, utilities, and his team's compliance with site and company environmental health and safety (EHS) programs. This role ensures that facilities, equipment, utilities, and infrastructure are maintained in a state of compliance and operational readiness to support manufacturing operations. The Senior Manager, Engineering Manager partners with Operations, Quality, Supply Chain, and other functional groups to drive operational excellence, facility reliability, regulatory compliance, workplace safety, and continuous improvement initiatives.

SUPERVISION EXERCISED

Under direct supervision of the Plant Manager this position will directly manage facilities and maintenance managers, supervisors, engineers, and technicians.

KEY RESPONSIBILITIES

• Lead engineering, facilities, maintenance, and utility operations to support manufacturing and business objectives.
• Ensure facilities, equipment, utilities, and infrastructure are maintained in compliance with applicable regulatory, safety, and quality requirements.
• Develop and implement preventive maintenance, calibration, reliability, and asset management programs.
• Manage engineering projects, facility modifications, equipment installations, utility upgrades, and capital improvement initiatives.
• Provide technical leadership for equipment qualification, facility validation, process improvements, and continuous improvement activities.
• Support manufacturing operations by identifying and resolving equipment, facilities, and process-related issues.
• Develop departmental budgets, capital expenditure plans, and resource forecasts.
• Manage contractors, vendors, and service providers to ensure work is completed safely, efficiently, and in compliance with company requirements.
• Coordinate facility inspections, repairs, maintenance activities, and utility monitoring programs.
• Ensure adequate capacity planning and infrastructure support for current and future business needs.
• Maintain facility drawings, engineering documentation, equipment records, and maintenance history files.

Environmental, Health and Safety Responsibilities

• Ensure his team’s completion of all required safety training and their compliance with site safety policies and procedures.
• Partner with EHS manager to manage facility emergency response programs, evacuation plans, and business continuity preparedness activities.
• Ensure contractor compliance with site safety requirements.
• Member of site EHS committee.

Quality and Compliance Responsibilities

• Ensure compliance with applicable FDA regulations, Quality System Regulations, ISO standards, OSHA requirements, environmental regulations, and company policies and procedures.
• Partner with Quality Assurance to maintain the effectiveness of the Quality Management System and support inspection readiness activities.
• Support internal audits, customer audits, and regulatory inspections.
• Ensure engineering and facilities documentation is maintained in accordance with Good Documentation Practices and quality system requirements.
• Participate in management reviews, risk assessments, and continuous improvement activities.

Training and Development

• Ensure personnel are properly trained and qualified to perform assigned responsibilities.
• Coordinate EHS orientation training and ongoing safety training programs.
• Support development of training curricula for engineering, facilities, maintenance, and EHS-related activities.
• Promote employee engagement, professional development, and technical competency growth.
• Perform other duties as assigned.

Skills & Competencies

• Bachelor's degree with a minimum of 8 years of relevant engineering, facilities, maintenance, or EHS experience.
• Minimum of 3 years of leadership experience in a regulated manufacturing environment.
• Experience in medical device, biologics, tissue technologies, pharmaceuticals, or other FDA-regulated industries preferred.

Preferred Qualifications

• Master's degree in Engineering, Environmental Health & Safety, Facilities Management, or Business Administration.
• Professional Engineering (PE), Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), or similar certification.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience supporting FDA inspections and ISO audits.

Tools And Equipment Used

• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.
• Software and systems: ERP systems (e.g., SAP), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

PHYSICAL REQUIREMENTS

• Sit, listen, speak, and move throughout various areas of the building.
• Travel across all company locations as needed.
• Periodically lift and/or move items up to twenty-five pounds.
• Travel domestically and internationally via car, train, or airplane, as required by the role.

Salary Pay Range

Salary Pay Range: $125,350.00 - $172,500.00 USD

Salary

Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

Employer Branding

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.