Engineer II - Manufacturing

Integer Holdings Corporation; Quakertown (Bucks County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Parental leave

Paid time off

Job summary

Integer Holdings Corporation is seeking an engineer to develop and improve medical device products from concept through manufacturing. You will work with cross-functional teams to design, analyze, and document engineering changes while ensuring quality and regulatory compliance.

The role emphasizes process improvement, tooling design, and deployment of manufacturing excellence strategies within a fast-paced environment. A bachelor’s degree and relevant experience are required.

Qualifications

• Bachelor's degree in engineering or related field required.
• At least 3 years of relevant experience in the medical device/engineering industry; or 7+ years if education requirement is not met.
• Ability to work independently and with cross-functional teams; strong problem-solving skills.

Responsibilities

• Lead design and development of new products and processes from concept to manufacturing.
• Review and approve engineering drawings, layouts, and specifications.
• Coordinate with other departments to plan and execute engineering activities and testing.
• Apply standard engineering methods and quality systems to ensure regulatory compliance.

Skills

Engineering fundamentals

Root cause analysis

Cross-functional teamwork

Documentation

Education

Bachelor's degree in engineering

Tools

IIoT systems

MES configuration

Engineering drawings

Job description

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

Who are we?

Guided by our Core Values of Customer Perspective, Accountability, Agility, Candor, Inclusion and One Team, our associates work together to improve patients’ lives around the globe, one device at a time. We stive to advance the goals of our medical device customers through industry-leading engineering and manufacturing, with a relentless commitment to quality, service and innovation.

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. 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 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 products. 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

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.

What sets you apart:

You earned, as a minimum, a bachelor’s degree in an engineering or related technical field; and have at least three years of relevant experience. Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience. While you will have occasional support and guidance from more experienced engineers, supervisors or managers, you will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams. You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual. You have a functional understanding of the Integer Quality Management Systems and are able to complete required Quality System documentation tasks with little or no direction from others. You demonstrate competency in both written and oral communications. 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.

Specialization

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.

Our total rewards program

• Our total rewards 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.

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.

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