System Engineer

4 weeks ago

Fridley, United States Transcend Full time

Company Overview

Join our dynamic team at Transcend Inc., a smaller medical device company dedicated to innovation and the people we serve.  We are the manufacturer of market-leading travel CPAP machines, helping those people with sleep apnea wherever they go. Our current device is about the size of a baseball – the smallest in the industry. We are highly focused not just on continuous improvement, but also continuous innovation to meet the requests of our customers.  We are currently seeking a Principal Systems Engineer to lead our engineering team and be part of our management team. Join us in making a meaningful impact on global health.

Your Role

The Principal Systems Engineer is a pivotal leadership role responsible for driving the development and integration of complex, end-to-end medical device systems as well as ancillary products. You will oversee the ecosystem encompassing devices, cloud infrastructure, mobile applications, software algorithms and intellectual property pipelines. You will apply systems engineering principles throughout the entire product lifecycle, from concept and design to verification, validation and product launch and sustaining activities. This hands-on role requires a good understanding of medical device regulations, a broad technical background spanning hardware and software, and excellent project management skills. You will be leading both the engineering team and cross-functional product development teams as well as be a key member of the Company’s management team. 

What you’ll be doing

  • Lead engineering activities across all stages of the product lifecycle, from new product development to post-market surveillance
  • Guide cross-functional teams through the product development process
  • Provide guidance on technical challenges and design trade-offs across the end-to-end product life cycle
  • Capture inputs for requirements from various sources such as sales/marketing, clinical and user needs, regulatory, quality, manufacturing and outside consultants and lead the process for defining product requirements
  • Drive solutions and product design realization from a systems perspective, using your knowledge of technology, processes, and therapy domains
  • Initiate, develop, and lead feasibility by crafting design concepts and research methodologies that best meet both current and future customer / business needs for products
  • Build and maintain design history files and ensure traceability
  • Facilitate an improved understanding of the interrelationship between requirements, risk and reliability
  • Anticipate technical challenges and risk scenarios and then prepare, lead, and execute mitigation strategies to ensure safe and effective results
  • Perform impact assessments on the requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigations, then propose recommended mitigations with the rationale
  • Manage project timelines, budgets, and resources to ensure all project goals are met
  • Drive consistency to FDA and ISO design control procedures, regulations, guidelines and standards
  • Teach and mentor other members of the engineering team
  • Contribute to the Company’s strategic planning and decision-making processes as part of the management team

Qualification Requirements:

Experience:

  • Minimum of 7 years work experience (primarily in medical device or related field). Some experience in a small company environment is preferred.

Knowledge/Skills/Abilities:

  • A demonstrated track record in electromechanical system development and commercialization, while effectively leading cross-functional teams
  • Self-starter with solid technical and problem-solving skills. Ability to make sound decisions, think critically and break down complex problems
  • Strong communication, presentation, and social skills, with the ability to influence and engage people at all levels
  • Strong understanding of medical device development processes, regulations and quality standards
  • Ability to work in a fast paced, team environment, meet deadlines, and prioritize and balance work for multiple individuals
  • Experienced project manager with the ability to manage multiple project timelines, budgets, resources, and activities across the engineering team

Education:

  • Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering or related fields required

Additional Information

Transcend Inc. is a manufacturer of award-winning continuous positive airway pressure (CPAP) medical devices. Since launching the world’s first travel-sized CPAP machine in 2012, we have continued to reimagine the functionality of small, portable CPAP machines. We are driven by our mission to provide sleep therapy solutions that allow CPAP users to successfully maintain their therapy regardless of lifestyle, travel plans or sleep location.  

Benefits:  We offer benefit plans that include medical, dental and life insurance, short and long-term disability coverage, 401(k) and paid holidays / personal time off.

How to Apply

  • Qualified candidates should submit their resume and a cover letter detailing their relevant experience and why they are a good fit for the role. Transcend Inc. is an equal opportunity employer.  

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