Design Quality Engineer, Assay (ADX-179-19)

| Greater Boulder Area
COMPANY OVERVIEW:
 

ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion and grit to meet these goals.

 

Make it happen by joining us in the fight against cancer.

 
POSTITION SUMMARY:
 
The Design Quality Engineer, Assay will serve as a subject matter expert on Archer’s design control project core teams. This position is expected to develop processes, author quality documentation, and disseminate expertise via training, mentoring and core team collaboration. 
 
RESPONSIBILITIES:
  • Own Archer’s CDx design control process by improving upon and executing quality management system documentation. Execution will include collaborating, via review and authorship of documents, with Archer’s core teams development teams in the creation of design quality documentation to support validated product design and submissions to regulatory authorities.
  • Act as a facilitator of risk management (ISO14971:2012) as it applies to the creation of a risk management file for the product under development. Utilizing the results of the risk assessment as inputs into the design verification protocols, design validation protocols, supplier stratification and process validations.
  • Support core teams in the planning, verification &validation, transfer and product launch.
  • Support as an SME for the Design History File during internal and external audits.
  • Where appropriate, manage external resources, such as consultants, on key initiatives by demonstrating accountability to management on timelines, costs and execution.
  • Assess project and infrastructure needs to create and execute and organizational plan to ensure proper support for all of Archer’s product and infrastructure obligations.
  • Support diligence audits, as a subject matter expert, by pharmaceutical partners (potential and current) as well as quality and regulatory authorities. When assigned findings for closure, demonstrate accountability and a commitment to continuous improvement by resolving issues in a timely manner.
  • Perform other duties as assigned by supervisor
 
QUALIFICATIONS:
  • 5 - 10 years in the design or development of regulated class II and/or class III IVD/medical devices.
  • Preferred companion diagnostic design control experience for
  • Demonstrable experience in medical device risk management, process validation, supplier development.
  • Experience in speaking for and defending design and validation documentation to external auditing authorities.
  • Certifications, such as ASQ, in quality assurance preferred.
  • Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
  • Ability to work independently, and utilize good problem-solving skills.
  • Ability to multitask and work within a fast-paced dynamic team environment. Archer is interested in a subject matter expert who will build collaboration among key departments rather than define functional boundaries.
EDUCATIZON:
  • Minimum-Bachelor's degree in a scientific field
 
 
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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