Medical Device Mechanical Engineer

ACL Digital; Thousand Oaks (CA); Hybrid; USD 80,000 - 110,000; Full time

Job summary

A technology solutions provider in Thousand Oaks seeks a Device Engineer to design and develop drug delivery devices such as prefilled syringes. The role involves conducting experimental testing, analyzing test data, and leading efforts to validate design changes. Candidates should possess strong laboratory testing experience, proficiency in statistical methodologies, and strong organizational skills. A Master's degree or equivalent experience is required. This position offers a hybrid work schedule and the chance to impact innovation in health technology.

Qualifications

• Strong laboratory testing experience, particularly with combination products and medical devices.
• Solid foundation in experimental methods and data analysis.
• Proficient in statistical tools and methodologies.

Responsibilities

• Conduct hands-on experimental testing for failure investigations and root cause analysis.
• Develop and refine test procedures to evaluate device performance.
• Analyze test data using statistical methods.

Skills

Problem solving (engineering skillset)

Organization (self-starter and project level management)

Communication (experience communicating at different levels)

Laboratory testing experience

Statistical tools and methodologies

Collaboration within cross-functional teams

Attention to detail

Education

Master degree

Bachelor degree and 2 years of experience

Associate degree and 6 years of experience

High school diploma / GED and 8 years of experience

Job description

Overview

The candidate will need to have availability to go onsite any day of the week, M-F. Hybrid schedule will be 3-4 days per week for the first 2 quarters and then determined depending on business needs.

Top qualifications

• A. Problem solving (engineering skillset)
• B. Organization (self-starter and project level management)
• C. Communication (experience communicating at different levels and to different groups)

Nice to have: 1-2 years of experience

Role

The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of Amgen’s combination product portfolio.

Key responsibilities

• Conducting hands-on experimental testing to support failure investigations and root cause analysis.
• Developing, executing, and refining test procedures to evaluate device performance and functionality.
• Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
• Supporting design changes by leading testing efforts to assess and validate proposed modifications.
• Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
• Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
• Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
• Enhancing and expanding Amgen’s delivery device platform as needed to meet evolving product and regulatory requirements.

The ideal candidate will

• Have strong laboratory testing experience, particularly with combination products and medical devices.
• Possess a solid foundation in experimental methods and data analysis.
• Be proficient in statistical tools and methodologies.
• Demonstrate experience in failure analysis and implementing design solutions.
• Have a proven ability to collaborate effectively within cross-functional teams.
• Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
• Show familiarity with regulatory and quality requirements for combination products and medical devices.

Opportunity

This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing Amgen’s portfolio of drug delivery devices.

Basic Qualifications

• Master degree OR
• Bachelor degree and 2 years of experience OR
• Associate degree and 6 years of experience OR
• High school diploma / GED and 8 years of experience