Summary
Bionano is seeking a skilled and detail-oriented Process Engineer to support and optimize the electronic assembly of complex electro-mechanical optical systems. This role plays a critical part in ensuring the consistency, quality, and efficiency of final assembly operations by thoroughly analyzing and documenting each step of the process.
Primary Duties and Responsibilities
- Analyze existing bring-up processes for complex electro-mechanical and optical equipment (20%)
- Develop detailed and standardized documentation (work instructions, process flows, etc.) to ensure process reproducibility and operator consistency (40%).
- Assist in training assembly personnel based on documented procedures (15%).
- Drive validation activities and provide technical input for manufacturing-related issues (5%).
- Work directly with contract manufacturers to review, verify, and align their assembly processes and documentation with company standards (5%).
- Participate in supplier audits and contribute to corrective/preventive action efforts when necessary (5%).
- Collaborate with cross-functional teams, including manufacturing and design engineering, to improve process robustness and yield (5%).
- Identify opportunities for process optimization and drive continuous improvement initiatives (5%).
- Other duties as assigned.
Required Skills and Abilities
- Demonstrated ability to analyze, document, and improve complex assembly processes.
- Strong communication skills and a hands-on, detail-focused mindset.
- Familiarity with ISO 13485 or similar quality standards.
- Experience working with optical components or precision mechanical assemblies.
- Background in process validation (IQ/OQ/PQ)
Education, Certifications, Licenses
- Education (Level and field of study) required/ preferred: Bachelor’s degree in Mechanical Engineering or a related field required
- Years relevant/ total work experience:
- 5-10 years in electronic final assembly operations, ideally in a regulated industry such as medical devices
Leadership Responsibility (Direct/ Indirect): N/A
Additional Requirements
- Work Location: Onsite – San Diego, CA
- Travel Requirements:
- 5% of travel time expected
- Local travel as needed
- Physical Requirements and Work Environment:
- Sit and stand for prolonged periods
- Repeating motions that may include the hands, wrists and/or fingers
- Use of hands to finger, handle, or feel, and reach with hands and arms
- Stand and/or move about the office
- Specific visual abilities, including close vision and ability to adjust focus, read, review, and assess the accuracy and thoroughness of the work assigned
- Verbal abilities require communicating with others to exchange information
- Occasionally adjusting or moving objects up to 10 pounds in all directions
- In-person interaction with others indoors
- Use standard computer, telephone and related equipment for communication, and recordkeeping
- Able to travel without personal assistance
The above physical requirements and work environment characteristics generally reflect those of this position but is not an exhaustive list. Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions of the position, provided that such accommodation does not impose an undue hardship on the Company. Disclaimer Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
This description generally reflects management’s assignment of essential functions but is not intended to be a comprehensive list of the duties and responsibilities of the position, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice.
