Production Engineer

BioProtect Medical•Headquarters, KY

22h•Onsite

About The Position

BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. Production & Validation Engineer is responsible for supporting and improving manufacturing operations within a regulated medical device environment. This role ensures that production processes are efficient, compliant and capable of consistently delivering high-quality medical products. The Production Engineer works closely with cross-functional teams including Quality, R&D, Regulatory, Maintenance, and Supply Chain.

Requirements

5 years of experience in the medical devices industry - a must
Good understanding in mechanics- a must
Professional experience with Solidworks
Clean room work experience including process validation
Familiarity with FDA and ISO 13485 medical device regulations. – a must
Familiarity with Design for Manufacturability and Assembly (DFM / DFA)
Good technical, problem-solving, and hands-on skills - must
BSc. Degree in Mechanical or Biotechnology Engineering.
Good analytical skills, self-starter with drive, focus, and initiative.
Language skills: Good English, both written and verbal
Self-starter with drive, focus, and initiative
Good communication and interpersonal skills
An ability of technical leadership in matrix and changing environment.

Responsibilities

Monitor daily production activities, troubleshoot issues, and provide timely technical support to maintain output and product quality.
Optimize manufacturing processes through root-cause analysis, cycle-time reduction, and waste elimination.
Develop and maintain work instructions and Test Instructions.
Collaborate closely with production and engineering teams Resolve process challenges within production facilities
Execute and document qualification/validation activities (IQ/OQ/PQ) per ISO 13485 and FDA 21 CFR 820 requirements.
Lead engineering investigation and Failure Analysis activities in Operation, on component, product or process level
Validate new equipment, fixtures, and tooling.
Support preventive maintenance programs and collaborate with maintenance to ensure equipment uptime.
Perform equipment capability studies and implement improvements.
Lead engineering activity regarding design changes (ECO), NPI, test method and tooling design, monitoring and continuous improvement of manufacturing processes
Design new Jigs based on improvement recommendations.
Supports MRB processes in Operation, assisting with issues relating to CAPAs, complaints and manufacturing support