Research And Development Engineer

Sriven Systems Inc.; Illinois; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Sriven Systems Inc. seeks an Engineer III to join the Combination & Medical Device Products team to maintain, support, and improve on-market consumable medical devices at the intersection of design, manufacturing, and regulatory compliance, ensuring post-market changes, material updates, and supplier transitions meet strict quality standards without disrupting supply.

The ideal candidate will have 3–5 years in medical device or pharmaceutical development, strong technical writing, and a proven

Qualifications

• 3–5 years in medical device or pharmaceutical/combination product development settings (office and lab).
• Excellent technical writing and cross-functional collaboration skills.
• Ability to manage post-market changes and supplier transitions.
• Experience coordinating ECOs and DHF traceability.

Responsibilities

• Manage post-market design and manufacturing changes and ECOs.
• Maintain DHF traceability across requirements, specs, risks, and V&V.
• Plan tests, investigate deviations, analyze data, and write reports.
• Collaborate with QA, Regulatory, Manufacturing and suppliers to streamline workflows.

Skills

Technical writing

Cross-functional communication

Problem solving

Project execution

Education

BS or MS in Bioengineering/ChE/ME

Tools

ISO 14971

ISO 10993

EU MDR

FDA 21 CFR 820

Job description

Location: North Lake County, IL (Hybrid)

Duration: 1 Year (Extension Possible)

Role Overview & Scope

The Engineer III will join the Combination & Medical Device Products team to maintain, support, and improve on-market consumable medical devices. This role sits at the intersection of product design, manufacturing, and regulatory compliance, ensuring that post-market design changes, material updates, and supplier transitions meet strict quality standards without disrupting supply.

Key Responsibilities

• Product Lifecycle & Change Execution: Manage post-market design and manufacturing changes, including evaluating design impact, processing engineering change orders (ECOs), and coordinating supplier transitions.
• Design History File (DHF) Traceability: Maintain and remediate DHFs to ensure full traceability between customer requirements, product specifications, risk management files, and verification/validation reports.
• Testing, Deviations & Data Analysis: Plan and execute test protocols, investigate deviations or out-of-specification results, analyze technical data, and author comprehensive technical reports.
• Cross-Functional Collaboration: Partner with Quality Assurance, Regulatory Affairs, Manufacturing, and external suppliers to communicate project status, resolve design challenges, and implement streamlined workflows.

Technical Standards & Knowledge Required

Applicable Standards & Tools

Quality Management Systems

ISO 14971 (Application of risk management to medical devices)

Biocompatibility

ISO 10993 (Biological evaluation of medical devices)

Regulatory Compliance

EU MDR (European Medical Device Regulation) & FDA 21 CFR 820

Ideal Candidate Profile

• Education: BS or MS in Bioengineering, Chemical Engineering, or Mechanical Engineering.
• Experience: 3–5 years in medical device or pharmaceutical/combination product development settings (office and lab environment).
• Soft Skills: Strong technical writing, cross-functional communication, problem-solving mindset, and project execution efficiency.