Engineer - Complaints Technical Investigator

Payrate: $40.00 - $44.00/hr.


Summary:
Company is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of Company's mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.


The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of Company's packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.


Responsibilities:

• Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends.
• Provide input to engineering for product improvements.
• Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms.
• Lead root cause analysis to identify the failure mode for Company's products and associated components due to product complaint.
• Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, "5 Whys", risk assessments such as FMEA's, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.
• Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation.
• Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data.
• Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Qualifications:

• The ideal candidate for this role will have at least 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices.
• They should be proficient with ISO systems, risk analysis processes, and protocol or report writing.
• A bachelor's degree in engineering or sciences such as chemistry, physics, or biology is strongly preferred, though candidates with other educational backgrounds who possess robust laboratory experience will also be considered.
• Experience working in biohazard lab settings is a plus, but not mandatory.
• Excellent written and verbal communication skills, along with strong presentation abilities, are essential as the role involves regular presentations to internal teams.
• Candidates must have a background in medical devices, biotech, or biopharma industries.

Preferred Qualifications:

• Master's Degree in Science
• 5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
• Understand customer / patient use of Company's packaged and/or distributed products
• Understand manufacturing processes for Company's packaged and/or distributed products
• Proven experience with medical devices
• Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
• Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
• Experience with protocol and report writing, process and test development and execution, and design of experiments
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Strong technical writing and interpersonal skills

Top 3 Must Have Skill Sets:

• Experience with protocol and report writing, process and test development and execution, and design of experiments
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Strong technical writing and interpersonal skills

Pay Transparency: The typical base pay for this role across the U.S. is: $40.00 - $44.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.


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