Process Engineer (Medical Device)

Autonomous Medical Devices Incorporated (AMDI), with its principal place of business in California, employs a world class team of engineers, scientists, clinicians, and manufacturing experts dedicated to the development and manufacture of point-of-care diagnostic devices using breakthrough microfluidics, protein engineering, and data/cloud connectivity. AMDI will launch its first products from its ISO:13485 certified 110,000 square foot facility in Santa Ana, CA.

Summary of Position

We are seeking a highly motivated engineer to join our dynamic biotech industry team. The Process Engineer will lead multiple aspects of manufacturing equipment and process design and validation. This position will be responsible for supporting the sustaining manufacturing and operations of Autonomous Medical Devices Incorporated. The Process Engineer will work closely with a cross functional team while maintaining equipment uptime and improving upon product cost, quality, and safety.

Location: This is an onsite position located at our Santa Ana, CA office. Candidates living within a 25 mile range preferred.

Essential Duties and Responsibilities

• Responsible for developing manufacturing and assembly processes consistent with Design for Manufacturability for new product introductions.
• Designs, executes and documents process validation protocols in support of quality and regulatory requirements.
• Provides on-demand pilot line support, managing manufacturing metrics (yields, cycle times, capacity, bottlenecks), ensuring adherence to quality and compliance procedures, identifying and implementing continuous process improvements, deploying new fixture and tooling, and supporting manufacturing documentation updates.
• Identifies and develops the crucial equipment related to new product development and maintains appropriate uptime for current equipment.
• Assists pilot line technicians and engineers on manufacturing problems. Purchases and designs equipment that meets safety and environmental requirements.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personnel and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Lead or support troubleshooting activities and process improvements. Perform root cause analysis of failures. Work on special projects as requested by management.
• Assist with other responsibilities and/or projects as the need arises.

Qualifications Required for Position

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field is required
• Minimum of 2 years of industry process engineer experience is required
• Experience with commercial or pilot manufacturing lines, technical report writing, statistical analysis and data evaluation is required.
• Knowledge of good manufacturing practices and documentation is required
• Strong Project Management experience and skills are preferred.
• The ability to influence others to achieve business objectives.
• Excellent written and oral communication skills is required.
• Knowledge of production processes, standard costs and work standards highly preferred
• Ensure personal and company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Experience in a regulated industry is required; medical device experience is a plus.
• Ability to travel up to 10%, international and domestic, is required.

Desired skills and traits

• Attention to Detail
• Communication (written and verbal)
• Computer Proficiency
• Leadership
• Microsoft Suite (Excel, Word, Outlook, PP)
• Seasoned experience in multiple facets of manufacturing operations
• Experience in Lean/Six Sigma.
• Hands-on leader who understands employee engagement, is a strong team builder, coach, and Understands the importance of culture and being true to the core values of the organization

Work Environment

• In-person position that requires working in a clean room environment that is humidity controlled.
• Personal Protective Equipment (PPE) will be required to be worn at some stations.

Autonomous Medical Device Incorporated offers a comprehensive compensation and benefits package to eligible employees including:

- Company provided lunch to all employees when working at one of AMDI's on-site locations.

- 401(k) match

- Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance

- Competitive vacation, sick days & paid holidays

- Tuition reimbursement

- Casual dress code

- Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc.

- Monthly company-wide socials

Autonomous Medical Devices Incorporated (AMDI) will not accept unsolicited resumes from any source other than directly from a candidate. An Agency must obtain advance written approval from AMDI's internal Human Resources team to submit resumes only in conjunction with approved valid fully executed contracts.

Our commitment to an inclusive workplace:

We are an equal opportunity employer and encourage people from all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.