Senior Design Assurance Systems Engineer - ENCHANNEL MEDICAL LTD

EnChannel Medical provides the opportunity to transform the future of cardiac arrhythmia through the power of technology. We are here to solve real-world problems and maximize global impact, fueled by the idea that our products will save lives, including our loved ones.

We are seeking a Senior Design Assurance Systems Engineer to join our team, and to spearhead and participate in diverse design assurance endeavors throughout the product lifecycle, spanning from design and development to manufacturing and post-market surveillance. We're seeking a thorough minded and analytical individual, driven by a passion to provide real-world solutions. You'll thrive in our fast-paced startup environment, collaborating with cross-functional teams to ensure excellence at every stage.

What you will be doing:

• Technical Documentation Development: Create comprehensive Technical Documentation for Medical Device File throughout design control phases for a medical device system.
• Test Method Assessment and Validation: Lead the assessment and validation of test methods to verify design integrity.
• Testing Participation & Oversight: Participate in engineering feasibility and official product testing, including third-party oversight.
• Report Preparation: Prepare Reports for official testing, conducting data analysis using risk-based statistics. 
• Design Assurance and Compliance: Review and approve change order content, ensure compliance with quality specifications, and contribute to updating quality system procedures and regulations.

What we are looking for:

• Experience and Education: Possess 5+ years of experience in the medical device industry, or 7+ years in a highly regulated field like Aerospace, along with a Bachelor's and/or Master's degree in engineering or equivalent. Experience with Medical Device Systems (including hardware and software) is a major plus.
• Risk-Based Approaches: Demonstrate familiarity with risk-based approaches and the ability to make informed risk-based decisions.
• Supplier Management: Show proficiency in working with Suppliers, including conducting Root Cause Analysis (RCA) and Supplier Audits.
• Design Assurance Skills: Have practical experience in investigating and documenting product non-conformances, with previous Operations & Quality Engineering experience being advantageous. Exposure to Post Market Surveillance activities, especially for customer complaints.
• Additional Skills: Knowledge of Design Control for medical devices or aerospace is a plus. Previous hands-on experience with Test Method Validation.  Ability to quickly learn technical electrical, mechanical, software concepts to support a cross functional team.
• Desirable but not required: Proficiency with Statistical Analysis tools like Minitab is advantageous, as is a working knowledge of Cybersecurity

What we offer:

• Amazing people and culture
• Competitive Salary
• Comprehensive benefits plan and 401K with company matching
• Stocked kitchen with snacks and drinks
• Casual dress and start-up work environment
• Wellness and fitness programs

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.