Sr. Process Development Engineer

Integer Holdings; Town of Clarence (NY); In loco; USD 105.000 - 154.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision coverage

401(k) plan with company matching

Parental leave

Paid time off & holidays

Descrizione del lavoro

Integer Holdings is seeking a Senior Process Development Engineer to lead process development and new product introductions in our medical device manufacturing facilities. You will design, validate and implement processes and equipment, optimize production lines, and mentor engineers while upholding quality and cost targets.

Ideal candidates have a bachelor's in engineering, 7+ years in process development, and certifications such as Six Sigma or PMP.

Competenze

• Bachelor's in engineering or related field required.
• 7+ years in process development or related role.
• Certifications such as Six Sigma or PMP preferred.
• Strong problem-solving and cross-functional collaboration.
• Experience designing and validating manufacturing processes.

Mansioni

• Lead process development for new products from concept to manufacturing.
• Plan and optimize production lines for efficiency and quality.
• Collaborate with design, manufacturing and quality teams.
• Develop and review testing protocols and process validations.
• Mentor engineers and technicians; provide coaching as needed.
• Ensure compliance with regulatory and Quality Management System requirements.

Conoscenze

Process development

Project leadership

Quality systems

Problem solving

Cross-functional teamwork

Manufacturing optimization

Formazione

Bachelor's in engineering

Master's in engineering (preferred)

Strumenti

PMP certification

Six Sigma

RCA

5-Why

Ishikawa

Descrizione del lavoro

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?

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 Medicaland 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.

Senior Process Development Engineer Salary: $105,000- $154,000

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.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.