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Nextern

Designs and manufactures medical devices

Manufacturing Engineer 2

Manufacturing EngineeringConfirmed live in the last 24 hours
Full-timeCartago Province, Cartago, Costa RicaNo salary listed

About the Job

Requirements

  • A Bachelor's degree in Electromechanical Engineering, Electrical Engineering, another field related to Medical Devices, or an equivalent combination of education and experience, plus at least five years of related experience and/or training.
  • Advanced-level English.
  • A U.S. visa and availability to travel for periods of 2–3 months.
  • Strong 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.
  • Attention to detail.
  • Knowledge of change control.
  • Ability to handle multiple projects and meet deadlines.
  • Good judgment and ability to make sound, timely decisions.
  • Knowledge of process validation.
  • At least five years of experience managing several production lines and multiple resources; experience in highly regulated industries such as medical devices or pharmaceuticals is preferred.
  • People-oriented and results-oriented approach.
  • High sense of urgency and leadership, with ability to coach operational and technical teams.
  • Strong interpersonal relationships across all levels.

Responsibilities

  • Coordinate product enhancements with customers and internal project teams.
  • Review high-level design requirements for alignment with Nextern's core competency and vision, review designs, and determine required bills of materials.
  • Work with supply chain to obtain bill of materials pricing from internal and external vendors.
  • Address manufacturing issues related to product quality and cost.
  • Support customer calls and presentations to compile product-sustaining activities.
  • Generate documentation supporting product and process development and manufacturing, including timelines, responsibilities, engineering protocols, IQ, OQ, and PQ reports, bills of materials, assembly instructions, manufacturing instructions, and procedures.
  • Conduct component and device testing protocols.
  • Develop plans to evaluate process repeatability and stability through equipment qualification and process validation.
  • Work with quality, supply chain, and product development to ensure compliance with QSR and internal protocols.
  • Work with internal manufacturing and outsourced partners to develop metrics, including labor time, yields, statistical analysis, process qualification and validation, and tooling and equipment qualification.
  • Transfer engineering projects from engineering into manufacturing as required.

Desired Qualifications

  • Experience in highly regulated industries such as medical devices, pharmaceuticals, or similar industries.

About the Company

Nextern

Designs and manufactures medical devices

Nextern designs and manufactures medical devices for equipment makers, with engineering and factory teams involved from early prototypes through production. Its work includes catheter-based instruments and electronic systems used in minimally invasive treatment and diagnostic procedures. Customers pay for development and contract manufacturing services, with project costs shaped by device complexity, materials and production scale. Its clinical markets include vascular and heart interventions and nerve stimulation, with services sold separately or as an integrated program. Founded in 2000 with industrial engineering roots, Nextern shifted to medical devices in 2016 and is headquartered in Maple Grove, Minnesota.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Maple Grove, MN
Founded
2000

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