Manufacturing Engineer

Integer Holdings Corporation; Woonsocket (RI); On-site; USD 90,000 - 140,000; Full time

Job summary

Integer Holdings Corporation in Rhode Island seeks an experienced engineer to apply advanced engineering principles across cardio/vascular and neuromodulation projects. You will lead cross-functional teams, develop protocols, ensure adherence to QMS and FDA regulations, and drive improvements that impact large programs.

The role emphasizes quality ownership, problem solving, and deployment of new technologies.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5+ years of progressive engineering and/or technically focused roles.
• Experience with quality systems and regulatory requirements (QMS, FDA).
• Lean Six Sigma training (green belt minimum, black belt preferred).
• Strong problem-solving and project-management capabilities.

Responsibilities

• Develop and lead engineering projects with moderate scope and impact.
• Plan and execute cross-functional initiatives with limited resources.
• Review documentation such as protocols and reports for accuracy and compliance.
• Drive continuous improvement and deploy new technologies.
• Collaborate with multiple units to align strategies and outcomes.

Skills

Project management

Leadership

Problem solving

Cross-functional collaboration

Quality systems

Education

Bachelor’s Degree in Engineering

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®.

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. Ensures Integer internal and external customers’ expectations are met or exceeded.

• 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 challenging problems and work on projects that 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 moderate scope and complexity.
• You may identify and procure the new equipment and technology of moderate 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 others.
• You will plan and develop engineering projects concerned with unique problems or team challenges, which have an important impact on moderate to large programs.
• You may lead cross-functional teams or projects with minimal resource requirements, risk and or complexity and may begin developing the skills to influence others to achieve goals.
• You will initiate and maintain relationships with individuals and business units within your site or organization.
• You will be proficient in specialty areas or technologies and are building advanced skills to become a subject matter expert. As a result, 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 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.

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 be an active supporter of 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 identify ways to shorten the project durations and make recommendations for systemic changes to current processes and procedures that enable greater efficiencies.
• 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 earned, as a minimum, a Bachelor’s Degree in an engineering or related technical field and may have earned a Master’s Degree.
• You are technically seen as a very competent technical contributor, a recognition you have earned through 5+ years of progressive engineering and/or technically focused roles and experiences.
• Candidates who do not meet the education requirement may be considered with 10+ 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 challenging technical issues result in the delivery of measurable 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 role 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.