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This position is responsible for developing and optimizing CNC machining processes for highly precise medical device components in a fast‑paced, regulated manufacturing environment. The engineer will lead programming, process validation, and continuous improvement initiatives to enhance quality, throughput, and overall operational performance.
The position leads design assurance activities for new product development, ensuring full compliance with FDA, ISO, and global medical device regulations. It drives quality engineering efforts across the product lifecycle, including risk management, verification/validation, and process validation, while supporting cross‑functional teams and suppliers.
This role supports manufacturing operations by ensuring strict adherence to quality system, regulatory, and documentation requirements for highly regulated products while monitoring production for compliance and product integrity. It also leads validations, risk analyses, CAPA activities, and continuous‑improvement initiatives while partnering cross‑functionally to strengthen processes and resolve quality issues.
The Director, Site Engineering Leader will provide strategic and technical leadership across a high‑volume manufacturing site specializing in extrusion, injection molding, and highly complex automation systems. This individual will guide a multidisciplinary engineering organization, ensure continuity of 24/7 operations, and play a critical role in shaping the site's long‑term growth, capital planning, and operational excellence.
The Senior Engineering Manager will lead and oversee all engineering and manufacturing operations, ensuring seamless project execution and team management. This role is pivotal in driving innovation and maintaining high-quality standards within the medical device sector.
The Engineering Manager blends hands-on technical work with team leadership. The role focuses on maintaining product compliance across Class I-III devices through updated test protocols, documentation, and design changes. You'll work closely with internal partners to ensure standards are kept current, gaps are identified early, and products continue to meet regulatory and customer expectations.
The Engineering Manager will oversee engineering functions that ensure efficient, compliant, and high‑quality medical device production. This leader will support manufacturing operations, drive continuous improvement, manage complex engineering projects, and guide a technical team through daily priorities and long‑term strategic initiatives.
The Engineering Manager will be a key hire to manage processes from beginning design phases all the way through production efforts. They will be a leader on the team to develop a smooth processes and life cycle of all products across Class I, II and III.
You will lead the charge in developing smart, scalable, and compliant manufacturing methods that keep our medical devices at the highest standards. This role guides a team of technical experts and drives major initiatives-from production scale‑up to high‑volume manufacturing-that are essential to our growth and product excellence.
This role leads engineering support for manufacturing operations, driving process improvements, resolving technical issues, and ensuring production quality and regulatory compliance. It also manages engineering projects, directs a team of engineers, and implements Lean and continuous‑improvement initiatives to optimize high‑volume medical device manufacturing.
The Engineering Manager will be a pivotal addition to a rapidly expanding manufacturing facility that is poised to double in size after securing a major new project and building out a new site. This leader will oversee all engineering and maintenance functions, guiding strategic growth by developing existing team members and supporting the integration of new hires as the operation scales.
Lead and inspire a team of Product Life Cycle Engineers while driving cutting‑edge testing, compliance, and design improvements that keep advanced Class I-III medical devices at the forefront of global standards. As a cross‑functional force‑multiplier, you'll shape product strategy, elevate quality, fuel innovation, and ensure every device delivers exceptional performance and unmistakable customer value.
You will lead the site's manufacturing engineering and automation agenda for a high‑volume, regulated production facility. Partnering closely with operations, you'll optimize complex extrusion, injection molding, and automated assembly lines to ensure safe, reliable supply of life‑sustaining products.
My client is seeking a skilled and detail‑oriented Depot Service Engineer to support the repair, maintenance, and technical evaluation of advanced equipment used in fertility treatment technology and fertility laboratories. This role is based within a centralized service facility and focuses on diagnosing, repairing, testing, and refurbishing medical devices and laboratory technologies that support critical reproductive workflows.
A new product line is entering development, and my client needs a Quality Manager to guide its design activities and ensure compliance throughout the process. This position will also take the lead in creating and organizing documentation for the company's quality systems and related programs. The employer is a specialized manufacturer that builds electro-mechanical solutions exclusively for the medical device industry
The Project Engineer is a key leader in managing and executing medical device manufacturing and product development initiatives. This role ensures projects are delivered on time, within scope, and in compliance with FDA Quality System Regulations and ISO 13485 standards, while driving innovation and efficiency.
This role serves as the U.S.-based quality and regulatory lead, ensuring full compliance with medical‑device regulations while overseeing quality systems, supplier performance, and imported product controls. It supports audits, design transfer, CAPA, inspections, and end‑to‑end oversight of global manufacturing partners to maintain product safety, documentation accuracy, and regulatory readiness.
This is a senior-level Quality Engineering role with a medical device manufacturer located near the Illinois-Wisconsin border. The position is responsible for leading and supporting all quality assurance and quality control activities within a metal fabrication manufacturing environment.
The Design Quality Engineer leads design assurance and quality activities across the product lifecycle to ensure compliance with FDA, ISO 13485, and EU MDR requirements for Class III medical devices. This role supports NPI efforts, provides technical guidance to engineering teams, and drives high standards in risk management, validation, and supplier quality.
This a brand new position for a publicly traded leading medical device organization in Burlington, Massachusetts and the Senior IT Compliance Analyst will be responsible for supporting the company's security and compliance initiatives, with a primary focus on the SOX ITGC framework.
We are seeking a Sales Account Manager specializing in injection molding to join a hybrid role in Nashua, NH area, providing top-tier service to the medical device market.
My client is a small start up company in the medical device space. They are seeking a highly motivated Product Engineer to join their team near Watertown, MA. In this role, you will work closely with surgeons and implement their feedback to improve and develop spinal implant devices.
My client is a global industrial manufacturer serving the automotive, aerospace, and medical device markets, and they are seeking a Senior Quality Engineer to join their expanding quality team. In this role, the Senior Quality Engineer will act as a key leader within the department, supporting Quality Management by driving major continuous‑improvement initiatives and leading both internal and customer audit activities.
This opportunity is an operations manager position with a metal fabrication company that specifically servies the top medical device OEM customers in the industry.
My client is a global industrial manufacturer for the automotive, aerospace, and medical device industries and is looking for a Senior Quality Engineer to join their growing quality department. The Senior Quality Engineer will be a leader on the team and will assist Quality Management with leading key continuous improvement quality projects and conducting internal and customer audits.
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