ABOUT ORGANOX:
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company's first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.
Position Summary
The position of Senior Process Engineer will work in the US Operations Department and is responsible for US Supply Chain, Operations and Logistics activities by working on the Continuous Improvement Projects that are identified. This will be achieved by designing, documenting, implementing and optimizing departmental processes used for operations, logistics and inventory management.
The Senior Process Engineer has the following key areas of responsibility:
- 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
Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the job holder will be expected to complete tasks reasonably requested by the Senior Manager, Operations. This is a flexible, on-site role in our Madison, NJ office.
Major Responsibilities
Under direction from the Senior Manager, Operations, the Senior Process Engineer will be responsible for:
- 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
Skills & Experience
- 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%)
Requirements
- 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%)
Qualifications
- 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
- Previous experience in supply chain and operations preferred
- Experience in the medical device industry preferred
- Good working knowledge of the Safety, Quality and Regulatory Standards (ISO 14971, IEC 60601, ISO 13485 etc.) required
- 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
- Ability to travel up to 10% of the time domestically and globally
Benefits
We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
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