Controls Design Engineer

Controls Design Engineer

As a Controls Design Engineer, you will ensure that design controls, risk management, verification/validation, and design transfer processes comply with ISO, FDA 21 CFR 820, and MDSAP requirements. You will establish and manage Design & Development procedures, including creating templates for Controls Design Plans, Inputs/Outputs, Reviews, and Design History Files (DHFs).

Responsibilities

• Drive risk management activities according to ISO standards, integrating hazard analysis and risk traceability.
• Author and review verification and validation protocols and reports, including equipment qualifications (IQ/OQ/PQ), material validation, and software lifecycle documentation in accordance with IEC standards.
• Support audits and submissions by providing subject matter expertise on design controls, risk management, and technical files.

Essential Skills

• 5+ years of experience in the medical device, dental device, or life sciences industries with a focus on design controls, new product development, and process validation.
• Proven track record of building design control frameworks from the ground up, preferably in startups or greenfield environments.
• Deep knowledge of ISO, FDA 21 CFR 820, MDSAP, ISO, and IEC (software lifecycle).
• Strong experience with hardware and material design verification, such as scanner systems, inks, or similar digital manufacturing devices.
• Experience leading design and risk reviews, and authoring Design History Files (DHF) and Device Master Records (DMR).

Additional Skills & Qualifications

• ASQ CQE/CQA, Six Sigma Black Belt, or ISO Lead Auditor certification preferred.

Work Environment

This position offers a full remote work environment, allowing flexibility and comfort in your working location.

Job Type & Location

This is a Contract to Hire position based out of New York, New York.

Pay and Benefits

The pay range for this position is $55.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 29, 2025.