Medical Device Embedded System Engineer Jobs in Fall River, MA

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The Medical Device Complaint Trending Expert is responsible for the end-to-end development, execution, and oversight of complaint data trending and signal detection activities to ensure timely identification of product quality, safety, and compliance risks. This role serves as a subject matter expert (SME) for complaint analytics, statistical trending methodologies, and regulatory expectations related to post-market surveillance.

The individual partners cross functionally with Quality, Regulatory Affairs, Risk Management, R&D, Manufacturing, and Medical Safety to translate complex complaint data into actionable insights that support corrective and preventive actions (CAPA), regulatory submissions, and risk management decisions.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Work end to end complaint trending data and analysis
• Identify trends within complaints being able to know the difference between variation vs signal.
• Design, maintain, and continuously improve complaint trending methodologies aligned with regulatory and business risk principles
• Perform routine and ad hoc trending analyses to identify statistically significant signals, emerging risks, and adverse trends
• Apply appropriate statistical tools and data visualization techniques to evaluate complaint data across products, failure modes, and geographies
• Establish alert thresholds, escalation criteria, and signal validation processes
• Support inspections, and audits with defensible trending analyses and documentation
• Author or review SOPs, work instructions, and templates related to trending and post-market surveillance
• Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions
• Collaborate with Medical Safety, Clinical, and Regulatory teams to evaluate patient safety and reporting impact
• Present trending results and risk assessments to management, governance boards, and quality review councils
• Serve as SME for complaint data systems and analytics tools (e.g., validated QMS systems, dashboards, and reporting platforms)
• Ensure data integrity, consistency, and traceability across complaint datasets
• Develop standardized dashboards, trend reports, and executive summaries
• Interpret and analyze complex data sets and clearly communicate findings to both technical and non-technical stakeholders
• Monitor industry best practices and regulatory guidance related to complaint trending and post-market surveillance
• Identify process improvements to enhance early signal detection, efficiency, and compliance
• Mentor and train colleagues on trending methodologies and regulatory rationale

• Bachelor's degree in Engineering, Life Sciences, Biostatistics, Data Analytics, or a related field
• Minimum 5-8 years of experience in medical device quality, complaint handling, post-market surveillance, or safety analytics
• Demonstrated expertise in complaint trending, signal detection, and root cause analysis
• Strong knowledge of global medical device regulations (FDA, EU MDR, ISO standards)
• Advanced analytical and problem-solving skills with the ability to interpret complex data
• Proficiency with statistical software or data visualization tools (e.g., Minitab, Power BI, Oracle, TrackWise)
• Strong knowledge of global medical device regulations (QMSR, EU MDR, ISO 13485, ISO 14971)
• Experience presenting to internal leadership as well as regulators/auditors.

Preferred Qualifications

• Advanced degree preferred

Additional Qualifications

• Strong oral and written English communication skills and effective interpersonal skills.
• Experience in FDA-regulated environment.
• Strong collaboration skills and experience working in a matrix environment.
• Ability to multitask, prioritize and meet deadlines.
• Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required.

Salary Pay Range:

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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