The Role
Hands-on manufacturing engineer responsible for process and equipment validations (IQ/OQ/PQ), creating equipment specs and fixture drawings, managing change control and documentation, supporting audits and regulatory compliance, training operators, coordinating tests and CAPA investigations, and collaborating with R&D, Quality, Production, and Supply Chain for new product introductions and process improvements.
Summary Generated by Built In
We are looking for a hands-on Manufacturing Engineer with a strong technical and operational focus, capable of leading implementations, validating processes, and collaborating with cross-functional teams. This role requires an active presence on the production floor, strong documentation skills, and excellent communication for effective client and team interaction.
Requirements
Responsibilities:
- Coordination of product enhancements with customers and internal project teams
- Review high level design requirements to evaluate whether they are within Nextern core competency and vision; review design and determine required Bill of Materials
- Work with supply chain to obtain BOM pricing (from internal and external vendors)
- Responsible for Manufacturing issues as it relates to product quality and cost
- Support customer calls and presentations to compile product sustaining activities
- Help to generate all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions and procedures.
- Help to conduct component and device testing protocols.
- Help to develop plans to evaluate process repeatability and stability through equipment qualification and process validation.
- Work with quality, supply chain and PD to ensure compliance with QSR and internal protocols.
- Works with internal manufacturing as well as outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment.
- Transfer as required engineering project from engineering into manufacturing.
Requirements:
- Bachelor's degree in Electromechanical or Electrical Engineering or another field related to Medical Devices and more than 5 or more years of related experience and/or training, or an equivalent combination of education and experience
- Advanced level of English
- Visa for USA and availability to travel for periods of 2-3 months
- Excellent oral and written communication skills
- Strong organizational, problem-solving, and analytical skills
- Ability to manage priorities and workflow
- Versatility, flexibility, and willingness to work within changing priorities with enthusiasm
- Attention to detail
- Change control knowledge
- Proven ability to handle multiple projects and meet deadlines
- Good judgment with the ability to make sound and timely decisions
- Process Validation knowledge is required
- Proven work experience managing several production lines and multiple resources of no less than 5 years, preferably in highly regulated industries such as medical devices, pharmaceutical or the like.
- People-oriented and results-oriented.
- High sense of urgency and leadership, demonstrated ability to coach operational and technical levels
- Exceptional interpersonal relationships across all levels
Skills Required
- Bachelor's degree in Engineering (Industrial, Chemical, Biomedical, or related)
- 2-4 years of experience in regulated manufacturing environments
- Intermediate to advanced English level (minimum B2, ideally C1)
- Experience creating equipment specifications and fixture drawings
- Strong experience with process validations (IQ, OQ, PQ) and documentation
- Hands-on approach with strong presence on the production floor
- Knowledge of line procedures and change control processes
- Excellent communication, negotiation, and customer service skills
- High adaptability, problem-solving ability, and teamwork orientation
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The Company
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
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