Systems Engineering Manager - Medical Devices & Lifecycle

BioSpace; North Chicago (IL); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Paid time off

401(k) plan

Job summary

A leading pharmaceutical company in North Chicago is seeking a Systems Engineering Manager to manage a team in ensuring the compliance of Design History Files for medical devices. The ideal candidate should have over 8 years of experience in operations and project management, strong problem-solving skills, and a Bachelor's Degree in Engineering. This role offers a comprehensive benefits package and opportunities for professional growth.

Qualifications

• 8+ years experience in operations and project management preferred.
• Familiar with regulatory standards (e.g., FDA 21 CFR 820.30, ISO 13485).
• Ability to identify and lead continuous improvement initiatives.

Responsibilities

• Lead Systems Engineers to ensure compliance of Design History Files.
• Standardize systems engineering activities to improve efficiency.
• Interface with 3rd party vendors as necessary.

Skills

Management experience

Problem solving

Decision making

Communication skills

Education

Bachelor’s Degree in Engineering or related discipline

Advanced degree in a technical field

Job description

A leading pharmaceutical company in North Chicago is seeking a Systems Engineering Manager to manage a team in ensuring the compliance of Design History Files for medical devices. The ideal candidate should have over 8 years of experience in operations and project management, strong problem-solving skills, and a Bachelor's Degree in Engineering. This role offers a comprehensive benefits package and opportunities for professional growth.