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New Product Design & Development Quality Engineer(Parkmore Galway)
Integer
Source: Headcount Labs · original listing ↗
Job data: Headcount Labs, ODbL 1.0. Job descriptions belong to their employers.
Posted Oct 28
About this role
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 JOB SUMMARY: The New Product Design & Development Quality Engineer will provide quality leadership, direction and technical guidance in quality assurance, quality control and preventive activities with a focus on preventive measures and continuous improvement of products and processes. Lead and strategize initiatives & projects to enhance quality performance within the business. Work with internal customers in support of quality issues and provide technical support for activities related to quality and performance evaluation. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: * Employees are expected to support the quality concepts inherent in the business philosophies of Integer including a variety of job-related tasks, which may not be specific to this position profile. * Provide quality engineering support throughout new product introduction, design transfer and product release activities. * Support the implementation and improvement of NPI processes and Lean Product Development practices. * Develop and review test strategies, protocols, reports and verification and validation (VV) documentation. * Support risk assessments and product lifecycle change management. * Support validation activities, throughout the product realisation process. * Ensure quality requirements are appropriately addressed throughout product development and manufacturing. Identify opportunities to improve product & process quality. * Work closely with project teams and customers to resolve quality issues and deliver projects that meet or exceed expectations. * Apply structured problem-solving and risk-based approaches to investigate issues and implement effective corrective and preventive actions. * Provide technical guidance, coaching and mentoring to engineers and technicians. * Collaborate with cross-functional teams to support successful product launches, process improvements and manufacturing release activities. SKILLS AND KNOWLEDGE: * Knowledge of manufacturing operations, systems and project management, including procurement, inventory control, quality control, production planning and control, test and inspection, layout. * Knowledge of engineering theories, methods and work measurement techniques. * Ability to apply engineering methods in the definition, design, research, development, utilization, maintenance, and cost-control of processes and equipment. MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: * Degree in Engineering/Science, with 1-3 years’ experience. * Working knowledge if IS013485:2016 and medical device manufacturing. PHYSICAL DEMANDS. * Work effectively with close tolerance parts & equipment. MENTAL DEMANDS. * Ability to work in an organized fashion in a challenging environment of competing priorities. * Excellent attention to detail. * Self-starter. WORKING CONDITIONS: Day-shift operation, but may be required to change working hours or work other shift patterns occasionally as project responsibility dictates. REPORTING RELATIONSHIP AND PRESENCE OR SUPERVISOR. This position reports directly to the Regulatory Affairs and Design Assurance Manager OUS IND1 U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply. 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. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical® and Lake Region Medical®. Additional information is available at [www.integer.net](http://www.integer.net/). 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 +716-759-5631 or via [TalentAcquisition@integer.net](mailto:TalentAcquisition@integer.net) 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](https://integer.wd1.myworkdayjobs.com/en-US/External/login) For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington. 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