Integer Holdings Corporation · 16 hours ago
Senior Design Assurance Engineer
Clarence, NY
Full-time
Onsite
Senior Level
$110K/yr - $161K/yr
7+ years expInteger Holdings Corporation is a leading company in the medical device industry, seeking a Senior Design Assurance Engineer to support their Design Assurance group. The role involves executing design verification and validation, coaching others in test method development, and ensuring compliance with regulatory standards throughout the product development process.
Health CareManufacturingMedicalMedical Device
Responsibilities
You will coach and mentor others to develop new test methods and improve existing methods including design and manufacture of new tooling, fixtures, and templates
Lead testing and validation of new test methods including gage R&R studies and statistical analysis of data through software packages such as Minitab
Create test method procedures and design assurance standard operating procedures as required
Lead and provide technical input into root cause analysis. Generate investigation reports within KPI metrics and timelines and route for approval. Participate and provide technical input on cross functional reviews of open field and customer returns
You will review and approve procedures, protocols, reports and other documents related to design assurance, test method development, product development and product testing and product validation which may be associated with new product development and introduction
Lead or coach a Cross Functional Project Team, providing design assurance support and expertise for development of new products through R&D/NPI. Participate and provide technical input in line with the product development process (PDP) and associated procedures
Ensure compliance at all stages of product development process (PDP)
Support planning execution of design verification & validation activities
Support planning execution of risk management activities per ISO14971
Operate and carry out product testing as required to support process and design validation, product development, or in supporting investigations of customer returns or complaints
Carry out periodic reviews of internal and external standards and identify potential gaps which require action
Ensure compliance of integer owned devices to state-of-the-art regulatory standards which DA are assigned
Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies
Participation in Site Hoshin Planning, Quality Planning, Validation master plans and associated quality improvement imperatives
You embed Quality within all that you do – “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
Associate Engagement promoted through the adoption of standardized problem solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems
Support systems & process optimization through adoption of principles of built in quality
You may perform other duties as needed and as directed by your line of supervision
Qualification
Required
At a minimum you have earned a bachelor's degree in an engineering or related field
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
You will have awareness of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
You will have good knowledge in Microsoft Office
You will demonstrate the ability to work independently as well as collaboratively with other associates and cross functional teams
You will 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 will demonstrate competencies in both written and oral communications
For outside of US countries, you will demonstrate competencies in both written and oral English communications
You will maintain a calm demeanor that transcends the high energy, constantly changing production environment
You will possess a positive, can-do attitude with an underlying belief that failure is not an option
You will be required to have a strong working knowledge of Statistics and the use of Minitab and be considered as an SME for statistics
Preferred
Preferably, you may also have a master's degree
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)
Company
Integer Holdings Corporation
Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.
10001+ employees
H1B Sponsorship
Integer Holdings Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.44BKey Investors
Disruptive Technologies Innovation Fund
2025-09-25Grant
2025-03-13Post Ipo Debt· $1B
2023-01-31Post Ipo Debt· $435M
Leadership Team
Payman Khales
President and CEO
Recent News
Company data provided by crunchbase