Principal Engineer, Manufacturing

at  BIOTRONIK

CRC EP, Inc., located in Tustin, CA, develops pulsed-field cardiac ablation (PFA) technologies. The team has recently completed the First-in-Human clinical trial which validated the company’s PFA technology. The team is embarking on preparing the technology for regulatory approvals followed by commercial release in respective territories. We are continually looking for talented engineers, scientists, and professionals to share in our mission.
Please join us as:
Principal Engineer, Manufacturing
CRC EP, Inc., located in Tustin, CA, develops pulsed-field cardiac ablation (PFA) technologies. The team has recently completed the First-in-Human clinical trial which validated the company’s PFA technology. The team is embarking on preparing the technology for regulatory approvals followed by commercial release in respective territories. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

SUMMARY:

This individual makes significant contributions to manufacturing engineering aspects of CRC-EP. The various tasks involve setting up a cleanroom, being involved in qualifications and a establishing successful production line for CRC EP PFA catheters.

EDUCATION / EXPERIENCE REQUIREMENTS:

• BS in Mechanical / Industrial Engineering or in an equivalent engineering discipline.
• 10+ years of experience in disposable medical device manufacturing/process development with at least 7+ years in cardiac ablation catheter manufacturing/process development.
• Solid knowledge of European MDR, GMP and ISO 13485:2016 regulations.
• Must be proficient in Solidworks and must be able to interpret technical drawings and specifications.
• Strong computer skills, including the MS Office suite (Word, Excel, PowerPoint).
• Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
• Must have demonstrated organizational skills to manage multiple priorities and schedules.

ADDITIONAL PREFERRED KNOWLEDGE, SKILLS, ABILITIES:

• Good written and verbal communication skills.
• Good organization skills.
• Excellent computer skills.
• Attention to detail.
• Analytical skills.
• Documentation skills.
• Reporting skills.
• Blueprint reading.

PHYSICAL REQUIREMENTS:

The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
• Must be able to work a minimum of 40 hours / week.

TRAVEL REQUIREMENTS:

Must be able to travel internationally and domestically, less than 10% of the time.
Location: Orange County
Working hours: Full-time
CRC SHD. Inc. California (US-CA) USA
Job ID: 59707
Micro Systems Engineering, Inc. is an Equal Opportunity/Affirmative Action Employer, Minority/Female/Disability/Veteran.
Micro Systems Engineering, Inc. believes that diversity leads to strength.

PRIMARY RESPONSIBILITIES:

• Develops and implements robust cost-effective cardiac ablation catheter manufacturing processes for new products.
• Executes design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control.
• Develops, tests and implements tools, fixtures and equipment required for cardiac ablation catheter manufacturing processes.
• Develops manufacturing process instructions, inspection plans and lot history travelers.
• Develops manufacturing process validation plans, according to MDR regulations, validation protocols and reports (e.g. IQ, PQ, OQs), and implements manufacturing process validations and test method validations.
• Develops and maintains cardiac catheter process risk documentation (e.g. pFMEA) to identify potential risks, and implement preventive and corrective actions.
• Manages and/or supports production and test equipment maintenance, qualification and calibration.
• Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures.
• Dispositions non-conforming products and develops required re-work procedures.

The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.
• Must be able to work a minimum of 40 hours / week