Senior Validation Engineer – Pharma/Med Device, Cross-Functional

ND Global Consulting Services, Inc; Ohio; On-site; USD 120,000 - 180,000; Full time

Job summary

ND Global Consulting Services, Inc. seeks a senior engineering professional to spearhead cross-functional product development within pharma/medical devices. You will drive architecture, design and verification activities, lead project plans, and guide junior engineers through PPQ processes.

The role requires a BS in Engineering with 10+ years in engineering processes, a strong background in combination products, and familiarity with 21 CFR 820, ISO 14971, and EU medical device regulations.

Qualifications

• BS in Engineering; pharma or medical device industry experience.
• 10 years current experience with engineering processes and procedures.
• Led projects from process development through PPQ approval process.
• Strong background in engineering for combination products.
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Experience in drug/device combination product assembly and packaging.
• Familiar with Quality System Regulation 21CFR820, ISO 14971, EU Medical Device requirements.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Strong problem solving, risk assessment, and risk management skills.
• Must be capable of working on multiple projects in a deadline driven environment.
• Qualified candidates with strong Electrical Engineering, Mechanical Engineering, Systems/Software Engineering background.

Responsibilities

• Work cross-functionally with Operations, Engineering and Automation teams.
• Create and assess product requirements for technical coverage and integration of subsystems.
• Create and execute project plans and schedules.
• Develop, execute, and review architecture and design documents and verification plans.
• Provide deep technical assistance for junior engineers.

Skills

Engineering Leadership

Pharma/Medical Device

Systems/Software Engineering

DOE/SPC

Education

BS in Engineering

Job description

ND Global Consulting Services, Inc. seeks a senior engineering professional to spearhead cross-functional product development within pharma/medical devices. You will drive architecture, design and verification activities, lead project plans, and guide junior engineers through PPQ processes.

The role requires a BS in Engineering with 10+ years in engineering processes, a strong background in combination products, and familiarity with 21 CFR 820, ISO 14971, and EU medical device regulations.