Research And Development Engineer

ATR International; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

ATR International is seeking a Senior R&D Engineer to lead sustaining engineering efforts for commercialized neurovascular medical devices, ensuring design controls, risk management, and regulatory compliance are met.

The role provides technical leadership, mentors junior engineers, and drives cross-functional collaboration with Manufacturing, Quality, Regulatory Affairs, and Suppliers to deliver robust solutions.

Qualifications

• Bachelor's degree in mechanical/biomedical/materials engineering or related field.
• Master’s degree in engineering is preferred.

Responsibilities

• Lead sustaining & released product initiatives with design controls and regulatory compliance.
• Lead root-cause investigations and CAPAs using structured problem-solving methods.
• Author/review design specs, risk analyses (dfMEA/pfMEA), test methods, ECOs, and technical assessments.
• Design testing protocols, analyze data, and demonstrate changes meet design intent and regulatory standards.
• Drive design improvements, obsolescence mitigation, cost-reduction, and supply continuity.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Supplier Quality, Marketing, Clinical, and Operations.

Skills

Sustaining leadership

Root-cause analysis

Design documentation

Data analysis

Cost optimization

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related engineering

Master’s degree in an engineering discipline

Job description

The Senior R&D Engineer is a key technical contributor within the Research & Engineering team. In this role, you will lead sustaining engineering initiatives to ensure commercialized neurovascular medical devices continue to meet all functional, quality, design control, risk management, and regulatory requirements.

As a seasoned individual contributor, you will provide technical leadership, deep subject matter expertise, and cross-functional oversight while mentoring and coaching junior team members.

Key Responsibilities

• Sustaining & Released Product Leadership: Evaluate and implement design, material, supplier, manufacturing, and labeling changes for commercialized products while ensuring strict compliance with design controls, risk management, and regulatory standards.
• Technical Investigation & Problem Solving: Lead root-cause investigations and develop technical rationales for product nonconformances, customer complaints, CAPAs, field issues, and supplier quality concerns using structured problem-solving methodologies.
• Engineering Documentation: Author, review, and approve critical engineering documentation, including design specifications, risk analyses (dFMEA/pFMEA), test methods, protocols, reports, engineering change orders (ECOs), and technical assessments.
• Design & Process Execution: Design testing protocols, execute data analysis, and author comprehensive reports to demonstrate that product and process changes maintain design intent and meet global regulatory standards.
• Supply Chain & Cost Initiatives: Drive technical execution for commercialized products, including design improvements, component obsolescence mitigation, cost-reduction initiatives, and supply continuity projects.
• Cross-Functional Collaboration: Partner closely with Manufacturing, Quality, Regulatory Affairs, Supplier Quality, Marketing, Clinical, and Operations teams to evaluate product performance, assess supplier/equipment qualifications, and implement effective solutions.

Hiring Manager's Top Priorities

• Sustaining / Released Product Engineering Experience: Direct background managing design and process changes for commercialized medical devices.
• Technical Investigation & Problem Solving: Proven ability to lead structured root-cause analyses for complaints, nonconformances, and CAPAs.
• Engineering Documentation & Cross-Functional Execution: Expertise in authoring design control documentation and executing projects across multi-disciplinary teams.

Qualifications & Experience

Education

• Required: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related engineering discipline.
• Preferred: Master’s degree in an engineering discipline.

Experience

• Bachelor’s Degree: Minimum of 5+ years of relevant engineering experience (preferably in the medical device industry).
• Master’s Degree: Minimum of 2+ years of relevant engineering experience.
• PhD: 0+ years of relevant engineering experience.
• Autonomy: Works independently under limited supervision to define and develop technical solutions; capable of project management and guiding junior engineers.
• Organizational Impact: Leads full projects or key processes within the department, driving consensus across teams to achieve strategic goals.
• Innovation & Complexity: Solves complex, multi-faceted engineering challenges and recommends process or product enhancements to elevate performance.
• Communication & Influence: Effectively communicates complex technical concepts, statuses, and rationale to internal leadership, cross-functional partners, and external vendors.
• Leadership & Coaching: Acts as a mentor to colleagues and provides guidance, delegation, and review of lower-level specialists' work product.