OrganOx · 1 day ago
Senior Process Engineer
Madison, NJ
Full-time
Onsite
Senior Level
$125K/yr - $135K/yr
7+ years expOrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. The Senior Process Engineer will work in the US Operations Department, focusing on Continuous Improvement Projects related to Supply Chain, Operations, and Logistics activities.
Health CareMedicalMedical Device
Responsibilities
Design, analyze and implement operational workflows across US operations and supply chain
Identify opportunities for process improvements and participate in continuous improvement initiatives
Develop and maintain technical process documentation, including Standard Operating Procedures, Work Instructions and Process Maps
Gather and report process metrics
Develop and maintain procedures that ensure compliance to ISO13485 for Operations Projects that fall under the scope of the OrganOx Quality Management System (QMS)
Create and review Specifications, Standard Operating Procedures and Work Instructions
Work closely with the Regulatory Affairs and Quality departments to ensure compliance with relevant medical device regulations
Create and review Change Controls (CCs), Risk Assessments (RAs), Root Cause Analysis investigations, Supplier Corrective Action Reports (SCARs), Nonconformance Reports (NCs), Corrective and Preventive Actions (CAPAs) and other internal & external documentation needed to support US Operations
Work collaboratively with colleagues at all levels in all departments to improve current processes and develop a culture of continuous improvement
Participate in the execution of US Operations Projects and work with cross functional teams to ensure successful execution
Support implementation of continuous improvement opportunities throughout the scope of operation for OrganOx Inc with the objective of improving Safety, Quality, Delivery performance and Cost
Collect and analyze process data and recommend improvements
Qualification
Required
A hands-on approach to developing, evaluating, and improving processes
The ability to evaluate, explain and simplify complex issues
Proven strong knowledge and understanding of process principles and engineering techniques
Previous experience in writing clear and concise Work Instructions, Standard Operation Procedures and other relevant Quality Documentation; acting as a Quality Technical writer
Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English
Experience with validation protocols (IQ/OQ/PQ), FMEA, and control plans
Proficiency in project management tools (e.g, MS Project, Smartsheet, or equivalent)
Strong and concise communication skills, both verbal and written
Ability to work effectively with outside suppliers and manufacturers
Self-motivated and driven to succeed
Very strong collaborative skills
Ability to work across a wide range of projects simultaneously
Ability to work well in teams
Willing and able to travel globally. (Up to 10%)
Bachelor's Degree in Process, Manufacturing, Biomedical, Industrial and Systems Engineering or related field required; master's degree preferred
Minimum 7 years of experience in process development, design and process implementation required
Strong Project Management skills
Good working knowledge of the Safety, Quality and Regulatory Standards (ISO 14971, IEC 60601, ISO 13485 etc.) required
Ability to travel up to 10% of the time domestically and globally
Preferred
Previous experience in supply chain and operations preferred
Experience in the medical device industry preferred
Good working knowledge or qualifications in improvement methodologies such as Lean or Six Sigma (Green Belt preferred)
Good working knowledge or qualifications in process Design & Review (DFx) preferred
Benefits
Health
Dental
Vision
Disability coverage
Flexible spending accounts
401(k)-retirement plan with company matching after 90 days
Paid time off
Holidays
Additional leave benefits
Employee discounts
Access to our onsite wellness facility
Opportunities for ongoing professional development
Company
OrganOx
OrganOx is a medical technology company.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$206.97MKey Investors
HealthQuest CapitalLauxera Capital PartnersBusiness Growth Fund
2025-08-23Acquired
2025-02-24Series Unknown· $160M
2025-02-24Secondary Market
Leadership Team
Steve Deitsch
Chief Financial Officer
Recent News
Medical Device Network
2026-01-07
2025-12-10
Company data provided by crunchbase