Sr Engineer, Design Quality (Medical Devices)

Location: Batesville, Indiana, United States. Applicants must be authorized to work for an employer in the U.S.; visa sponsorship is not available.

Estimated base salary: $96,000–$132,000 annually, with possible discretionary bonuses, commission, and/or long-term incentive.

Company

hirify.global develops healthcare products and works to improve healthcare delivery and sustain lives.

What you will do

• Provide quality support and oversight for New Product Development and Sustaining Engineering projects.
• Identify and assess regulatory and quality risks according to regulatory requirements and hirify.global quality practices.
• Support design activities including planning, inputs, outputs, reviews, verification, validation, transfer, and design changes.
• Compile and maintain product Design History Files in collaboration with R&D.
• Partner with Sustaining Engineering and R&D to ensure thorough and robust design reviews.
• Support quality assurance, compliance, risk management, and product lifecycle activities for medical devices.

Requirements

• Bachelor’s degree in engineering.
• 3–5 years of Quality experience in a medical device, pharmaceutical, or similarly regulated industry.
• Strong problem-solving and root cause analysis skills.
• Working knowledge of medical device design controls and product lifecycle management for New Product Development and sustaining activities.
• Working knowledge of quality system and risk management requirements, including ISO 13485, ISO 14971, Regulation (EU) 2017/745, and U.S. FDA Quality System requirements.
• Knowledge of applicable IEC and ISO product standards, such as IEC 62304, IEC 60601-1, and ISO 62366-1, for the assigned product scope.
• Ability to review technical documentation and assess whether requirements, methods, results, conclusions, and traceability are scientifically and objectively supported.
• Ability to apply or critically review statistical methods for verification, validation, reliability, sampling, and process or product data analysis.
• Strong written and verbal communication skills, with the ability to explain complex quality or technical topics to technical teams and management.
• Self-motivated, organized, detail-oriented, able to manage multiple priorities, and able to maintain accurate and complete records.
• Ability to challenge constructively, make decisions, and escalate concerns when evidence is insufficient or patient safety, product quality, or compliance may be affected.
• Experience working in an environment subject to 21 CFR Part 820 requirements.

Nice to have

• Experience with 5 Why, fault tree analysis, design or process FMEA, DMAIC, or equivalent structured methods.
• Experience supporting audits or regulatory inspections, including FDA inspections.
• Professional certification in quality engineering, reliability, software quality, Lean, or Six Sigma.

Culture & Benefits

• Collaborative Quality team partnering with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality.
• Shift flexibility, including the ability to trade shifts and access overtime opportunities.
• Medical, dental, and vision coverage from day one.
• 160 hours of paid time off, paid holidays, paid parental leave, and additional family and medical leave benefits.
• 401(k) matching, employee stock purchase program, tuition reimbursement, and other financial and educational benefits.