Process Development Engineer II

Integer Holdings Corporation; Town of Alden (NY); On-site; USD 72,000 - 106,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Adoption benefits

401(k) with company matching

Paid holidays

Job summary

Integer Holdings Corporation in the United States is seeking a Process Development Engineer II to join our team. The role focuses on developing processes and equipment to introduce new products into manufacturing sites, while ensuring safe, high-quality, and cost-effective results.

You will work within a broader NPI team, applying QMS and FDA regulations, and collaborating with engineers and managers to optimize production lines and improve processes.

Qualifications

• Develops processes and equipment to introduce new products into manufacturing sites.
• Evaluates existing processes and implements improvements to ensure safety, quality, and cost efficiency.
• Adheres to Quality Management Systems (QMS) and FDA regulations in all activities.
• Collaborates with cross-functional teams to drive manufacturing excellence.

Responsibilities

• Develops processes and equipment to introduce new products into manufacturing sites.
• Validates processes and manufacturing lines to ensure quality and efficiency.
• Leads process improvements and optimizes production layouts.
• Plans, schedules and executes engineering work on major projects.
• Applies data analysis to establish root causes and justify improvements.

Skills

Engineering

Process development

Quality systems

Regulatory compliance

Root cause analysis

Job description

Who are we?

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers’ success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right

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’ll do in this role:

The primary purpose of this position is to perform work which involves general engineering methods and tools; but you may also utilize more advanced technologies and engineering concepts while you are developing in your role as an engineer in the medical device industry. In this role, you will ensure that Integer’s internal and external customer expectations are met or exceeded with occasional direction, instruction and guidance from more experienced engineers and managers in your organization. Develops processes and equipment to introduce new products into manufacturing sites with the goal to ensure 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.

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 generally work independently with occasional guidance from supervisors or mentors to evaluate, select and apply standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications to existing specifications, procedures, and work instructions.

You will review procedures and plans prior to implementation as well as evaluate existing products, processes and materials for failure analysis and potential improvements. You will participate in projects that require you to investigate, develop, document and implement new product and process technologies of moderate complexity and scope. While often you may be responding to situations presented to you by others, you will also be able to demonstrate proactive insight into technical challenges and mitigates potential issues or incorporates improvements.

You will plan, schedule and execute the engineering work in a part of a major project; or you may lead a smaller scope project. You will perform work on technical projects where you will follow Integer’s standard quality management and production system methodologies to investigate opportunities for product and process improvements. You will apply standard data analysis practices and techniques to establish root cause for product and process failures or to support the justification for improvements to products and processes. You will be required to observe products and processes to recognize discrepancies in results and follow operations throughout a series of detailed steps or processes to establish root cause of the discrepancies. You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer. 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 may 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 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.

Process Development Engineer II Salary:

Salary: $72,000- $105,600 #IND1

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

Equal Opportunity & Diversity

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply. Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination. Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment. Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at [phone] or via [e-mail] so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in to https://integer.wd1.myworkdayjobs.com/en-US/External/login

Further Information

Additional information is available at www.integer.net.