Post-Market R&D Engineer II

CardioQuip • College Station, TX

12d

About The Position

Post-Market R&D Engineers collaborate with cross-functional teams to support released CardioQuip products throughout the post-market lifecycle. The role covers engineering investigations, product and process improvements, design changes and transfer, complaint investigations, manufacturing support, post-market data review, and maintenance of compliant engineering and quality documentation.

The engineer independently carries out routine lifecycle-management and post-market maintenance activities, including controlled changes from problem definition through technical justification, risk assessment, verification and validation, documentation, and implementation. The position also leads or coordinates routine design transfer, investigations, complaint handling, manufacturing-line audits, and sustaining activities. It works with contract manufacturers, suppliers, Service, distributors, and customers to address technical issues and support product and supply continuity, while communicating project progress, risks, budgets, and timelines to management and stakeholders.

The position requires a bachelor’s degree in a relevant engineering field and at least one year of relevant industry experience. A one-time relocation stipend is offered if relocation is required.

Requirements

• Completed bachelor's degree in a relevant engineering field.
• At least 1 year of relevant industry experience, preferably in the medical device industry.
• Ability to analyze technical and post-market data, exercise sound engineering judgment, and translate findings into appropriate recommendations.
• Excellent organizational, technical writing, oral, and interpersonal skills.

Nice To Haves

• Project management experience or CAPM certification.
• Experience with medical device design controls, design history and technical documentation, change control, risk management, root cause analysis, FMEAs, CAPA, design verification and validation, process validation, statistical methods, and risk-based design.
• Experience supporting released medical device products through design changes, manufacturing investigations, supplier changes, design transfer, or other post-market R&D engineering activities.
• Knowledge of manufacturing processes, engineering drawings and bills of material, DFM/DFA/DFS, and production problem solving.
• Knowledge of and experience with medical-device regulations and standards, such as FDA QMSR, 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, IEC 60601, IEC 62304, and IEC 62366, as applicable.
• Ability to lead routine project planning, scheduling, budgeting, and tracking efforts.

Responsibilities

• Execute routine lifecycle-management and post-market maintenance activities for released products, including controlled product and process changes from problem definition through technical justification, risk assessment, verification and validation, documentation, and implementation.
• Lead or coordinate routine design transfer activities for new products and product changes, including manufacturing readiness, drawings and bills of material, work instructions, inspection and test methods, training support, and production documentation.
• Analyze post-market, service, manufacturing, complaint, and customer feedback data to identify trends, technical issues, product performance concerns, and improvement opportunities, and recommend appropriate actions.
• Lead routine engineering investigations and root cause analyses for product, manufacturing, service, and complaint issues; troubleshoot, evaluate, and implement or coordinate corrective actions.
• Perform assigned Engineering complaint-handling activities, including customer communication, device investigations, complaint determinations and documentation, risk assessments, corrective-action or CAPA evaluations, and assigned reportability determinations, regulatory reporting documentation, and approvals.
• Plan, draft, execute, and document verification, validation, and process validation activities supporting product design changes, technical investigations, and engineering improvements.
• Conduct routine engineering manufacturing-line audits and observations to verify adherence to approved procedures, work instructions, and manufacturing practices; document findings and coordinate follow-up.
• Maintain design, manufacturing, risk-management, and change-control records for assigned products in accordance with applicable standards, regulations, and CardioQuip quality requirements.
• Work with contract manufacturers, suppliers, Service, distributors, and customers to resolve technical issues, evaluate changes, and support product and supply continuity.
• Coordinate cross-functional sustaining activities and update management and stakeholders on project progress, risks, budgets, and timelines.
• Participate in continuous improvement of engineering and sustaining processes and in outreach for prospective engineering talent.
• Perform other duties as assigned.

Benefits

• One-time relocation stipend if relocation is required.
• Competitive salary commensurate with experience and qualifications.
• Health, dental, and vision insurance.
• Retirement savings plan with company contribution.
• Paid time off, including vacation days and holidays.
• Supportive team culture that values innovation, improvement, and empowerment.

What This Job Offers

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