Engineer I - Detroit MI

VetJobs; Detroit (MI); On-site; USD 90,000 - 110,000; Full time

Job summary

Amgen in Detroit, MI is seeking an Engineer I to join an electromechanical device engineering team focused on final product development of drug-device platforms. You will ensure safety, efficacy, and functionality across the product lifecycle and maintain design documentation per quality procedures.

Responsibilities include leading test strategies, managing design history files, data analysis for performance and deviations, and collaboration with suppliers to meet regulatory filings.

Qualifications

• Master’s degree or equivalent in engineering or related field.
• Bachelor’s degree with 2 years of engineering/operations experience, or an Associate’s degree with 6 years, or a high school diploma with 8 years experience.
• Experience in medical device or pharmaceutical environments preferred.
• Strong knowledge of quality systems and regulatory standards (21 CFR 820, ISO 13485, ISO 14971).

Responsibilities

• Provide guidance on combination product and device design requirements and specifications.
• Lead product test strategies to demonstrate safety, performance, and efficacy.
• Manage Design History Files for combination products.
• Analyze data to support acceptance, performance, and failure analysis.
• Create and drive test protocols, methods, and reports.
• Transfer technical information to manufacturing sites and support scale-up.

Skills

Regulatory knowledge

Technical writing

Device design

Education

Bachelor's degree

Master’s degree

Associate’s degree

High school diploma / GED

Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Engineer I

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of a development and sustaining device engineering team that supports final product development of Electromechanical Device Platforms. You will be responsible for ensuring the product meets all requirements for safety, efficacy, and functionality through product lifecycle management. You will manage the creation and maintenance of design documentation in accordance with quality procedures. You will be part of multi-functional teams responsible for the development of drug-device combination products.

Responsibilities

• Providing guidance on combination product and device design requirements and specifications
• Leading product test strategies and execution to demonstrate product safety, performance, and efficacy
• Manage combination product and device Design History Files
• Analyzing data to support design acceptance, performance capability, and failure analysis
• Creating and driving test protocols, methods, and reports
• Transferring of technical information to manufacturing sites and support manufacturing scale-up and launches
• Employ basic engineering skills and practices to gather user requirements and translate them into documentation
• Engaging suppliers and development partners regarding specifications and quality levels
• Provides authorship and expert technical leadership for regulatory filings
• Managing project scope, schedule, and budget
• Owns and support quality records, change records, and deviations
• Supports device design complaint investigations and tracking to ensure timely resolution and continuous improvement
• Collaborate with Process Development and external partners as a technical authority.

Minimum Education Required

High School/GED

Additional Qualifications/Responsibilities

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.

Basic Qualifications

• Master’s degree
• Or
• Bachelor’s degree and 2 years of Engineering and/or Operations experience
• Or
• Associate’s degree and 6 years of Engineering and/or Operations experience
• Or
• High school diploma / GED and 8 of Engineering and/or Operations experience

Preferred Qualifications

• Bachelor's degree in engineering or other science-related field with 5+ years of relevant work experience with demonstrated ability in operations/manufacturing environment
• Experience in medical device, pharmaceutical or a similar regulated industry
• Background in development and commercialization of medical devices, and knowledge of manufacturing processes

Understanding Of The Following Standards And Regulations

• Quality System Regulation – 21CFR820
• Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices – ISO 14971
• Excellent communication and technical writing skills

City

Detroit

State

Michigan

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen

Salary Range

>$100,000