Integer Holdings Corporation
Senior Design Assurance Engineer (Chaska)
Integer Holdings Corporation, Chaska, Minnesota, United States, 55318
Senior Design Assurance Engineer (Chaska) page is loaded## Senior Design Assurance Engineer (Chaska)locations:
Chaska, MNtime type:
Full timeposted on:
Posted Todayjob requisition id:
R32965By 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 rightKey Accountabilities and Responsibilities* Adheres to Integ Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.* As a quality Core Team member, plays a key role on development project teams. Performs quality/reliability engineering activities while providing guidance and expert advice to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.* Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device.* Generates and/or reviews and provides guidance for related project deliverables, such as design verification and design validation protocols and reports as well as process validation protocols and reports. Works cross functionally with R&D and provides expert guidance in the review of technical documentation.* Leads and provides guidance with Product Development Manufacturing Engineering in development of test, develop production acceptance criteria, test methods, and process validation protocols.* Leads and provides guidance for sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination. Is the SME for standards interpretation and statistical methods.* Leads and provide guidance for root cause analyses investigations, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required.* Performs other functions as required.Job RequirementsMinimum Education: Bachelor’s Degree in Engineering or related field required. Master’s Degree preferred.Minimum Experience: 7-10 years of experience.Specialized Knowledge:* Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive.* Practical knowledge of ISO 14971 and related standards* General familiarity with industry best practices in development, testing and manufacturing processes.* Medical device sterilization process.* Experience in interpreting design schematics and design drawings.* Preferred experience with FDA and European regulated medical devices* Demonstrated proficiency in statistical methods e.g. ANOVA, SPC, test sample size plans, Gauge R&R, and DOE.* Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).* Proficient in establishing and implementing quality metrics for product development.Special Skills:* Strong collaboration, negotiation, and conflict resolution skills.* Ability to lead team activities and coach.* Excellent communication, presentation, follow through and organizational skills, verbal and written communication skills to be applied at all levels of the organization. * Excellent technical writing skill* May travel up to 10% .* Salary Range-$122,100-$179,080Our 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.**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 .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 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 toFor remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.**To review the Integer U.S. Applicant Privacy Statement click****.** #J-18808-Ljbffr
Chaska, MNtime type:
Full timeposted on:
Posted Todayjob requisition id:
R32965By 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 rightKey Accountabilities and Responsibilities* Adheres to Integ Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.* As a quality Core Team member, plays a key role on development project teams. Performs quality/reliability engineering activities while providing guidance and expert advice to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled.* Leads Risk Management (ISO 14971) and Usability program activities. Leads cross function teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device.* Generates and/or reviews and provides guidance for related project deliverables, such as design verification and design validation protocols and reports as well as process validation protocols and reports. Works cross functionally with R&D and provides expert guidance in the review of technical documentation.* Leads and provides guidance with Product Development Manufacturing Engineering in development of test, develop production acceptance criteria, test methods, and process validation protocols.* Leads and provides guidance for sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination. Is the SME for standards interpretation and statistical methods.* Leads and provide guidance for root cause analyses investigations, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required.* Performs other functions as required.Job RequirementsMinimum Education: Bachelor’s Degree in Engineering or related field required. Master’s Degree preferred.Minimum Experience: 7-10 years of experience.Specialized Knowledge:* Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive.* Practical knowledge of ISO 14971 and related standards* General familiarity with industry best practices in development, testing and manufacturing processes.* Medical device sterilization process.* Experience in interpreting design schematics and design drawings.* Preferred experience with FDA and European regulated medical devices* Demonstrated proficiency in statistical methods e.g. ANOVA, SPC, test sample size plans, Gauge R&R, and DOE.* Demonstrated proficiency utilizing quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe).* Proficient in establishing and implementing quality metrics for product development.Special Skills:* Strong collaboration, negotiation, and conflict resolution skills.* Ability to lead team activities and coach.* Excellent communication, presentation, follow through and organizational skills, verbal and written communication skills to be applied at all levels of the organization. * Excellent technical writing skill* May travel up to 10% .* Salary Range-$122,100-$179,080Our 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.**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 .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 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 toFor remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.**To review the Integer U.S. Applicant Privacy Statement click****.** #J-18808-Ljbffr