Senior Process Development Engineer

Integer Holdings Corporation; Town of Clarence (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Integer Holdings Corporation in the United States seeks an experienced engineer to lead design and development of new products and manufacturing processes. You will coordinate across engineering, manufacturing, and quality to bring concepts into safe, high-quality production with cost efficiency.

The role demands a hands-on leader able to mentor technicians, manage complex projects, and drive improvements across departments.

Qualifications

• Bachelor's degree in engineering or related field; master’s preferred.
• 7+ years of progressive engineering and/or technically focused roles.
• Strong problem-solving and leadership skills with cross-functional collaboration.
• Experience with process improvements and quality systems (QMS/ISO).

Responsibilities

• Lead design engineering activities across products and processes from concept to manufacturing.
• Plan and execute into production with scale-up and risk mitigation.
• Direct cross-functional teams and coordinate documentation, tests, and validations.
• Develop new processes, tooling, and layouts; mentor junior engineers and technicians.

Skills

Project leadership

Problem solving

Technical communication

Team coaching

Education

Bachelor's degree in engineering or related field

Master's degree (preferred)

Tools

Six Sigma

8D

RCA

PMP

Job description

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMOs) in the world, serving the cardio and vascular, neuromodulation, and cardiac rhythm management markets. As a strategic partner of choice, we advance the goals of our medical device customers through industry-leading engineering and manufacturing, with a relentless commitment to quality, service, and innovation. The company's brands include Greatbatch Medical® and Lake Region Medical®.

What you will do in this role:

The primary purpose of this position is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. You will ensure that Integer internal and external customers’ expectations are met or exceeded. Develop processes and equipment to introduce new products into manufacturing sites with the goal of ensuring safe, high-quality, and cost-effective results. Identifies existing or develops new process and equipment technology, characterizes and optimizes processes, and validates processes and manufacturing lines. As part of a broader new product introduction team, establishes efficient production line layouts or leads process improvements to existing plant operations. May perform estimations of production times, staffing requirements, and/or related costs.

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 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.
• You will develop new and unique approaches to complex problems and lead projects to advance Integer’s technological capabilities.
• You will investigate and interpret internal or external technology and business trends and recommend best practices to the organization.
• You will evaluate, develop, and implement a wide range of new technologies of significant scope and complexity.
• You may identify and procure the new equipment and technology of significant complexity, scope, and cost.
• You will originate new documents such as protocols, reports, specifications, and work-instructions; and you may also review documentation work product of peers and subordinates.
• You will plan and develop engineering projects concerned with unique or high-profile problems which have an important impact on major programs.
• You may lead cross-functional teams or projects with moderate resource requirements, risk and or complexity and may influence others to achieve goals.
• You may provide supervision for up to 4 to 5 technicians and/or associate engineers. Also, you will serve as a coach and mentor for other engineers, where you will be modeling the behaviors and disciplines of an engineering or technical professional.
• You will initiate and maintain relationships with individuals and business units within or outside your site or organization. And, as a subject matter expert in an engineering or specialty field, you may be directed to deploy your expertise across multiple organizations and/or locations. As a result, occasional travel may be required in this position.
• 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 Operation 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.

How you will be measured:

• The specific measures listed below may be subject to change and are not intended to be an all-inclusive list
• Safety is our highest priority; you will support the Integer Environmental, Health & Safety programs.
• Quality – Achievement of site Quality KPI’s
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Given your capabilities and experience, you will be expected to identify ways to shorten project durations and lead to systemic changes to current processes and procedures that enable greater efficiency.
• Innovation and ideation are critical aspects of your role, and you will be expected to generate continuous improvement suggestions and support the implementation of them.
• Your expertise coupled with your accomplishments and collaboration with others to deliver results will also be considered.

What sets you apart:

• You have earned, as a minimum, a bachelor's degree in an engineering or related technical field. Preferably, you may also have a master's degree.
• You are technically seen as a subject matter expert, a recognition you have earned through 7+ years of progressive engineering and/or technically focused roles and experiences.
• Candidates who do not meet the education requirement may be considered with 15+ years of relevant experience.
• You have a strong technical and problem-solving foundation, and preferably 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.
• Your abilities to observe, analyze and develop solutions to complex technical challenges result in the delivery of break-through results in areas such as productivity, technical capabilities, capacities, or other competitive differentiators.
• You work independently as well as collaboratively with cross functional teams.
• You will demonstrate the 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 are important in this position and you will have well-developed written and oral communication skills.
• You maintain a calm demeanor that transcends the high energy, constantly changing production environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.