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Nextern

Designs and manufactures medical devices

Senior Project Engineer

Project ManagementConfirmed live in the last 24 hours
Full-timeBen Cat, Ho Chi Minh City, Ho Chi Minh, VietnamNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree or higher in an engineering field or related technical degree is required; Computer Science, Computer Engineering, and Electrical Engineering are preferred, and PMP certification is a plus.
  • A minimum of six years of total medical device development or regulated industry experience, including at least five years of project management experience.
  • Ability to identify problems and develop and implement solutions.
  • Ability to make timely, value-adding decisions at all organizational levels.
  • Ability to develop effective responses and plans for people, problems, or issues.
  • Ability to communicate ideas, arguments, and solutions effectively and work through conflict resolution internally and externally.
  • Ability to plan for, implement, and communicate negotiation elements that create value while maintaining supplier relationships.
  • Competence with project management tools, procedures, and programming languages used for the role.
  • Excellent written and verbal communication skills; Mandarin speaking and/or reading ability is beneficial.
  • Excellent written and verbal communication skills in English.
  • Ability to translate, statistically analyze data, and report problems effectively in written or graphical formats.
  • Customer service skills and advanced understanding of internal and external customer relationship building.
  • Ability to use Microsoft Word, Excel, PowerPoint, and project tools; knowledge of Smartsheet, Celoxis, and PLM systems is beneficial.
  • Interpersonal and teamwork skills, including the ability to influence, motivate, mentor, and direct team resources.
  • Ability to solve complex problems and implement solutions using available resources.
  • Engineering experience, training, and knowledge in electromechanical and medical device work sufficient to understand and communicate with engineering teams and check or review their plans and progress.
  • Organizational, reasoning, planning, and motivational skills.
  • Effective meeting practices, including attendance, agendas, start and stop times, minutes, actions, and follow-through.
  • Ability to adapt processes to improve inefficiencies and accelerate outcomes.
  • Strong working understanding of ISO 13485 and cGMP product development requirements.
  • Ability to occasionally stand, walk, climb, balance, bend, stoop, kneel, or crawl; continually sit, use hand and finger dexterity, and talk or hear; occasionally lift or move more than 40 pounds; and perform work requiring close vision.

Responsibilities

  • Perform project management responsibilities for cross-functional activities within the New Product Development team and sustaining projects.
  • Work with engineering, quality, and production team leads and management to create and track schedules, budgets, performance targets, resource plans, prioritization, task delegation, and planning activities for engineering deliverables.
  • Provide visibility into project schedule and budget issues, manage escalations, and coordinate critical issue resolution with the project engineering team lead, business development manager, and Vietnam leadership management.
  • Provide the project management interface to project leads and critical internal and external client stakeholders to coordinate and execute critical activities and project management functions efficiently.
  • Assess and highlight risks, develop mitigation plans, and actively participate in the risk management process.
  • Ensure cross-functional communication through effective meetings, email, and other means to coordinate engineering functional areas and other departments.
  • Ensure successful completion of project stage gates and related activities required for compliance with the company's ISO 13485- and cGMP-compliant design and development process.
  • Ensure proper documentation for each development activity and adequate documentation for the Design History File, product manufacturing, and ongoing production, including test procedures, drawings, and bills of material.
  • Conduct post-mortem reviews on key developments and lead communication of further design improvements to projects.
  • Interpret, implement, and monitor modifications to department methods, processes, and policies that affect multiple work groups.
  • Provide input and plan for program-related expenses, engineering quotations, budget development, and forecasting.
  • Carry out other duties as assigned by management.

Desired Qualifications

  • PMP certification is a plus.
  • Mandarin speaking and/or reading ability is beneficial.
  • Knowledge of Smartsheet, Celoxis, and PLM systems is beneficial.

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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