IVD Systems Engineer Job at BEPC Inc. - Business Excellence Professional Consulting, Pleasanton, CA

bDN1UzRDOVlLZlRDZnM4NnpKNVlCWXRvM0E9PQ==
  • BEPC Inc. - Business Excellence Professional Consulting
  • Pleasanton, CA

Job Description

Job Title: IVD Systems Engineer

Location: Onsite – Local Candidates Only

Employment Type: Contract

Pay Rate: $60 - $65/hr

Role Overview:

BEPC is seeking a highly experienced IVD Systems Engineer to join our client's System Development team. In this role, you will lead the design and development of innovative in-vitro diagnostic (IVD) automation systems, driving cross-functional collaboration throughout the product lifecycle. This includes requirement development, risk management, validation testing, and regulatory compliance—all while mentoring junior engineers.

Key Responsibilities:

  • Lead development and integration of automated IVD systems.
  • Translate customer needs into systems-level requirements.
  • Execute risk management activities per ISO 14971.
  • Plan and perform system validation and verification.
  • Produce compliant documentation and project deliverables.
  • Troubleshoot system defects and manage changes.
  • Ensure alignment with applicable regulatory and quality standards.
  • Promote process improvements and best practices across teams.
  • Mentor and guide junior systems engineers.
  • Support regulatory submission efforts and audits.

Qualifications:

  • Bachelor’s in Systems, Biomedical, Electrical Engineering, or related field; advanced degree preferred.
  • 5+ years in the medical device industry, preferably in IVD systems.
  • Familiarity with liquid handling platforms (e.g., Hamilton, Tecan) is a plus.
  • Strong experience with requirements development and design inputs.
  • Expertise in ISO 14971 and systems risk management.
  • Excellent problem-solving, analytical, and communication skills.

Job Tags

Contract work, Local area,

Similar Jobs

Joan & Alan Bernikow JCC of Staten Island

Summer Camp Counselor (Seasonal) Job at Joan & Alan Bernikow JCC of Staten Island

 ...which includes Olympic sized pools, an archery range, basketball courts, lake for boating, amphitheater, playground, gaga courts and sports fields. This position includes Counselors and Specialists. About You You are a fun, energetic, caring and mature person who... 

MIMO Technik

CNC Specialist : Programing & Machinist Job at MIMO Technik

 ...by the world's largest OEMs for space and flight-critical hardware. Role Description This is a full-time, on-site role for a CNC Specialist machinist in Los Angeles, CA. The position will be responsible for developing the department alongside our current lead application... 

Hearst Digital Marketing Services

Digital Account Executive Job at Hearst Digital Marketing Services

 ...strategies. Access to existing scripts and coaching resources. Training on prospecting tools and best practices. Utilize our online learning management system. Benefit from best-in-class sales tools, including Salesforce and Gong. Currently accepting... 

The Goodkind Group, LLC

Ultrasound Technologist Job at The Goodkind Group, LLC

 ...experience: M-F / 8:00 am - 4:30 pm ( Could be Long term temp to perm / Schedule could be a little flexible) Perform high quality ultrasound procedures in strict accordance with currently approved practices as outlined in department policy and procedure manuals,... 

AD Energy Recruitment

Plant Operator - Renewable Natural Gas (RNG) Job at AD Energy Recruitment

 ...Job Title: Renewable Natural Gas (RNG) Plant Operator Location: Ringle, Wisconsin Employment Type: Full-Time Reports To: Plant Manager Position Overview We are seeking a dedicated and skilled RNG Plant Operator to oversee the daily operations and maintenance...