What are the responsibilities and job description for the Manufacturing Process Engineer - Med Device position at BIK HR Consulting LLC?
Only direct/local candidates need apply.
We are representing Organ Recovery Systems in order to fill this critical role to lead and manage the Company's network of contract manufacturers.
Company Description Organ Recovery Systems is a global market-leading provider of organ preservation products and services, supporting more than 400 transplant programs across 49 countries. Since 2003, its LifePort Kidney Transporter has been used in over 275,000 renal transplant procedures worldwide. Team members contribute to a mission-driven organization focused on innovation in lifesaving transplant technologies.
Primary Responsibilities
· Act as the primary operational contact for contract manufacturers.
· Partner with contract manufacturers to resolve manufacturing issues.
· Coordinate directly with ORS Quality and Engineering teams.
· Manage supplier performance across quality, delivery, and cost metrics, and drive corrective actions.
· Provide sustaining engineering support, including root cause analysis, CAPA execution, and MRB activities.
· Lead supplier-related projects such as process transfers, IQ/OQ/PQ validations, and capacity expansions.
· Support new product introduction through supplier selection, RFQ development, and manufacturing readiness planning.
· Drive quality improvement initiatives and participate in supplier compliance activities.
· Collaborate across Quality, R&D, and Supply Chain functions.
Job Requirements
· Experience in medical device or regulated manufacturing environments (FDA/ISO 13485).
· Strong understanding of Device Master Records (DMR) and manufacturing documentation.
· Hands-on experience with injection molding, assembly, or electro-mechanical systems.
· Proficiency in quality tools such as FMEA, SPC, and problem solving.
· Demonstrated project management and cross-functional leadership capabilities.
· Ability to communicate effectively with suppliers and executive stakeholders.