Product & Sustaining Engineer

Organization
ArcherDX
Job Location
2477 55th Street
Boulder, CO 80301
Benefits

We offer competitive compensation and generous benefits programs.

Job Description

Position Overview

ArcherDX Inc, (“Archer”) is seeking an experienced Product & Sustaining Engineer for its growing enterprise. The Product & Sustaining Engineer would have cross–functional responsibilities in Production, Quality, and Engineering in support of the new Archer devices. Archer is looking for an individual that can assure and maintain the design integrity and quality of the products; develop, document and improve the manufacturing processes (including assembly and test), make product design improvements including cost reductions and reliability improvements, support the production and materials teams at our contract manufacturer, and increase customer satisfaction through continuous product and process improvement, complaint analysis, and identification and implementation of innovative approaches to problems. This position will report directly to the technical lead in R&D, and may also be directed in part by Product and Quality Assurance Management. The position requires knowledge and capability in design and manufacturing of fluidic systems, implemented in portable, disposable formats.

 

Ideal Candidate Characteristics

 

  • Demonstrated ability to thrive in a rapidly changing, fast-paced environment

  • Ability to set a project plan and work within an interdisciplinary team, as well as independently, to meet the goals

  • Excellent ability to multi-task

  • Excellent writing and communication skills

  • Provide direct/quick responses to product line and team needs

  • Interact and represent the company in a positive, professional, and ethical fashion at all times

  • Strong desire to be part of a very dynamic, growing, and mission driven company

 

Essential Duties/Responsibilities

 Manufacturing and Quality System process development activity:

 

  • Support the QMS systems and standards framework

  • Development, maintenance and continuous improvement of manufacturing processes and equipment

  • Support continued compliance with all regulatory requirements and worldwide regulatory authorities, including ISO and FDA

  • Coordinate and document internal and external process validations

  • Evaluate components, subassemblies and full units for performance and work with component suppliers to adjust dimensional and material specifications to optimize design for manufacturability

 

Product Design / Development Engineering:

 

  • Generate and execute engineering changes, including document approval.

  • Generate and execute design verification and process validation protocols and reports

  • Maintain risk documentation including Design and Process FMEAs and Risk Reports

  • Development and execution of design qualification testing including biocompatibility, shipping, packaging, aging and sterility testing

  • Investigate and resolve customer complaints using systematic problem solving techniques and implementation of innovative solutions to address root cause

 

Production and Materials Support:

 

  • Operations sign off on new product development documents

  • Develop assembly/test methods and equipment

  • Coordination of pilot production runs/design verification builds

  • Participate and lead projects to decrease product cost and improve product quality

  • Resolve supplier quality issues

Requirements

Job Requirements and Qualifications

Education:

  • B.S. in Mechanical or Biomedical Engineering

Desirable Training (licenses, programs, or certificates):

  • Medical device manufacturing

  • Microfluidic design and implementation

  • Project management

  • GMP/ISO knowledge skills

  • Statistical process control

  • Design of Experiments

Required skills and experience:

  • Minimum of 2-5 years relevant professional medical device experience

  • High proficiency in Solidworks, including working with complex assemblies of microcomponents and interfaces requiring tight tolerances.

  • Knowledge of Medical Device Risk Management procedures

  • Strong critical thinking skills

About Our Organization

Join the genomic healthcare revolution on our motivated, empowered and enterprising team designing and promoting cutting-edge next-generation sequencing assays.

We are ArcherDX, a Boulder, Colorado-based emerging leader in next-generation DNA sequencing technology used to detect cancer mutations in clinical sample types. We are scientists, developers and engineers using precision genomics to make personalized medicine a reality. We are adventurers who rock climb, snowshoe, race motorcycles, ski, fly, volunteer and brew beer. We are highly focused people that recognize talent, expect hard work and collaboration and reward openly. We also kick back after work and enjoy pool, foosball, quadcopter wars and the weekly brew.  

We are looking for people who are driven to excel in a high-paced yet casual environment, embrace tough assignments, see challenges as opportunities to grow, desire their work to have a direct impact on company success, and thirst for knowledge through experience. 

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