Integer Holdings Corporation · 2 weeks ago
Process Development Engineer III
Hudson, MA
Full-time
Onsite
Senior Level
5+ years expInteger Holdings Corporation is a global organization providing innovative technologies and manufacturing to Medical Device OEMs. The Process Development Engineer III will conduct research and development projects related to new product design, resolve technical problems, and support ongoing production operations while ensuring adherence to quality standards.
Medical DeviceHealthcareManufacturingHealth CareMedical
Responsibilities
Conducts research or development projects associated with the design and the development of new products or models
Investigates and resolved technical problems involving product performance
Coordinates development and design problems with research engineering, tooling, and manufacturing
Follows up on the building of design and life test models, analyzing the test results
Follows through on laboratory and field tests and develops new ideas based on results
Supports ongoing production operations and is the primary technical support resource for production lines
Typically, works directly with production associates daily to support process and equipment as well as responds to resolve technical issues that arise during production operations
Develops, details, and implements process and equipment solutions which improve safety, quality, delivery and cost on existing production lines
Develops and procures tooling, fixtures, and equipment used in manufacturing that optimize productivity, maintainability, and cost
Creates and maintains manufacturing documents and digital operations systems (IIOT systems) including engineering drawings, BOMs, routers, process work instructions, engineering change orders, and MES configuration modeling
Leads equipment qualification and process validation tasks
Collaborates with cross-functional teams to evaluate and influence designs for manufacturability, cost reduction and business growth projects
Interacts with manufacturing, quality and supply chain associates to identify process improvement opportunities and to evaluate/disposition non-conforming products as needed
Establishes and executes corrective and preventative action plans to remediate system quality or operational concerns and proactively takes action to mitigate potential for production operations failures
Participate in cross-functional project teams to implement creative solutions
Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues
Interfaces with Quality and R&D to integrate new products or processes
Responsible for identifying and correcting manufacturing process nonconformance’s identified during prototype builds
Works with the product monitoring group on complaint investigations and supports the DPRA process
CAPA owner for any CAPA’s related to the design of the product
Coordinates with the manufacturing site on product transfers by leading the design transfer process
Supports the manufacturing site on any design or process related changes
Supports the supplier quality team on for supplier changes that might impact the product design
You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
Initiates, directs and manages the design, and development of new products and processes from concept to commercial manufacturing
Works closely with other departments to coordinate design engineering activities
Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications
Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling
Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project
Develops and /or reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials
Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications
Devises new approaches to problems encountered
Prepares all necessary paperwork and documentation for all projects undertaken
You embed Quality within the Engineering discipline – 'I own Quality.'
You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to 5 Sigma
You perform other duties, as needed and as directed by your line of supervision
Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies
You champion the development of and deployment of the systems and tools to drive innovation and continuous improvement
You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas: Strategy Alignment through Site Hoshin Plans, the regular cadence of Sales, Inventory, and Operations’ Planning (SiOP) meetings, and regular updates to the value stream maps
Leadership of Sustained Change by ensuring production monitoring & improvement activities and deployment of Leader Standard Work
Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs
Associate Engagement promoted through the adoption of standardized problem solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems
Systems & Process Optimization through adoption of principles of built in quality, optimized scheduling & material system designs, work cell design, and total productive maintenance
Qualification
Required
Bachelor's Degree in an engineering or related technical field
5+ years of progressive engineering and/or technically focused roles and experiences
Strong technical and problem solving foundation
Ability to observe, analyze and develop solutions to challenging technical issues
Ability to work independently as well as collaboratively with cross functional teams
Ability to lead team activities and act as a coach for other less experienced associates
Clear and professional communications to all levels of the organization
Well-developed written and oral communication skills
Ability to maintain a calm demeanor in a high energy, constantly changing production environment
Positive, can-do attitude with an underlying belief that failure is not an option
Preferred
Master's Degree
Training and certifications in a variety of problem-solving and project management methodologies such as 6-Sigma (green belt as a minimum, black belt preferred), 8D, RCA, 5-Why, Ishikawa (Fish Bone), Kepner-Tregoe, PMP
Company
Integer Holdings Corporation
Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.
10001+ employees
H1B Sponsorship
Integer Holdings Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.44BKey Investors
Disruptive Technologies Innovation Fund
2025-09-25Grant
2025-03-13Post Ipo Debt· $1B
2023-01-31Post Ipo Debt· $435M
Leadership Team
Payman Khales
President and CEO
Recent News
Company data provided by crunchbase