Post Market Surveillance Engineer II

Integer Holdings Corporation • Plymouth, MN

18h • $70,950 - $104,060

About The Position

The Post Market Surveillance Engineer II executes and supports Integer’s complaint handling, regulatory reporting, and post-market surveillance processes, with guidance from more experienced associates and managers. The role analyzes, evaluates, and investigates complaints from external customers in a timely manner to meet FDA 21 CFR (QSR) and other applicable regulatory requirements. It also supports product quality and patient safety through complaint investigations, risk and CAPA assessments, adverse-event reportability decisions, regulatory submissions, and post-market trending activities.

The position supports internal and external audits, regulatory inspections, customer audits, quality-system projects, process improvement, and Integer’s manufacturing excellence and market-focused innovation strategies. The role requires collaboration with internal and external customers and cross-functional teams, while upholding Integer’s values and safety, environmental, security, and quality requirements. The employee may handle, decontaminate, and analyze products used in the field in accordance with internal procedures and safety requirements; relevant vaccinations may be required.

Performance is evaluated in part through safety and values adherence, defined goals and project milestones, site quality KPIs, and contributions to innovation and continuous improvement. The role may include other duties as directed by the line of supervision.

Requirements

• Bachelor’s degree and at least 1 year of relevant experience; candidates who do not meet the education requirement may be considered with at least 3 years of relevant experience.
• Ability to work independently and collaboratively with associates and cross-functional teams.
• Solid technical aptitude and ability to contribute effectively to a team or produce technical results individually.
• Effective written and oral communication skills.
• Strong organization skills and ability to manage and track multiple projects and complaints simultaneously.
• Intermediate to advanced proficiency with Microsoft Office applications, including PowerPoint, Visio, Project, Excel, and Word.
• Ability to comply with applicable quality, safety, environmental, security, company, and regulatory requirements.
• Relevant vaccinations may be required if handling, decontaminating, and analyzing field-used products.

Nice To Haves

• Medical-device or other regulated-industry experience is preferred.

Responsibilities

• Accurately capture and document complaints in the complaint-handling database according to internal policies and procedures.
• Send complaint acknowledgements to customers and track customer-return products.
• Perform complaint investigation activities with cross-functional team members, including reviewing device history records for nonconformities related to alleged complaints.
• Interface with internal and external customers to gather information for investigations and prepare customer communications, investigation reports, and customer-facing reports as applicable.
• Collect data, conduct root-cause investigations, and support resolution of complaints involving product quality and patient safety.
• Help ensure complaint investigations are closed on time to meet FDA and other regulatory requirements.
• Handle, decontaminate, and analyze products used in the field when required, following internal procedures and safety requirements.
• Perform risk assessments for Integer-owned designs.
• Perform CAPA assessments and support CAPA investigations.
• Assess adverse-event reportability under U.S. and international regulations and assist with forms for reportable complaint submissions to applicable agencies.
• Gather complaint and shipment data to support post-market trending, PMSRs, and PSURs.
• Support internal and external audits, regulatory inspections, and customer audits, including timely responses to and closure of audit findings.
• Work on quality-system projects using Integer’s standard methodologies to investigate process-improvement opportunities.
• Support Integer’s Manufacturing Excellence and Market Focused Innovation strategies, including site planning, quality planning, validation master plans, and quality-improvement initiatives.
• Support QA/RA weekly and monthly metrics and continuous improvement toward 5 Sigma.
• Lead sustained change as required, including initiating and completing customer change notifications as necessary.
• Support workplace organization and visual controls (5S), manufacturing standard work, and training and certification programs where applicable.
• Promote associate engagement through standardized problem-solving methods, behavior-based safety programs, and improvement idea and suggestion systems.
• Support systems and process optimization through built-in-quality principles.
• Actively support Integer Environmental, Health & Safety programs, adhere to Integer’s values, meet defined goals and milestones, and contribute improvement suggestions and their implementation.
• Collaborate with others, exchange information, ask questions, and check for understanding as part of ongoing development.
• Perform other duties as needed and directed by the line of supervision.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Disability insurance
• Life insurance
• Adoption benefits
• Parental leave after one year
• Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance
• 401(k) plan with company matching contributions
• 80 hours (10 days) of company-designated holidays per year
• Annual paid time off allotment
• Base salary and cash-based incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level