Senior R&D Engineer - Medical Devices, Quality & Compliance

Enhanced Compliance Inc.; Marlborough (MA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Equal opportunity employer

Flexible benefits

Job summary

Enhanced Compliance Inc. is seeking a seasoned Quality/Regulatory professional to drive compliance across medical devices from design through validation. The role focuses on quality input, documentation, and adherence to FDA/ISO standards.

You will collaborate with cross-functional teams to ensure robust design controls, risk management, and verification activities. Strong communication and team leadership are essential in this contractor/FT capacity.

Qualifications

• 5–6 years' direct R&D experience in medical devices (electromechanical).
• Experience with durable medical capital equipment preferred.
• Excellent written and verbal communication with good presentation skills.
• Knowledge of FDA Quality Systems Regulations (21 CFR 820) required.
• Demonstrated use of quality tools: SPC, DOE, GR&R, FMEA, CAPA, and process validation.
• Must understand FDA 21CFR820, ISO 13485, 14971, 11607 standards.

Responsibilities

• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling).
• Develop quality documentation such as quality plans and SOPs; ensure FDA/ISO compliance.
• Represent Quality initiatives during design and phase reviews; lead quality practices.
• Lead implementation of Acceptance Activities, First Article Inspections, sampling plans, and product testing.
• Apply systematic problem-solving to identify and resolve quality issues; support CAPA/NCRs/Complaints.
• Assist with special projects as needed.

Skills

Quality assurance

Regulatory compliance

SOP writing

DOE

CAPA

Statistical methods

Design review

FDA knowledge

Education

Bachelor's degree

Tools

SPC

FMEA

GR&R

DOE

Job description

Enhanced Compliance Inc. is seeking a seasoned Quality/Regulatory professional to drive compliance across medical devices from design through validation. The role focuses on quality input, documentation, and adherence to FDA/ISO standards.

You will collaborate with cross-functional teams to ensure robust design controls, risk management, and verification activities. Strong communication and team leadership are essential in this contractor/FT capacity.