Senior Risk Management Design Quality (ADX-29-20)

| Greater Boulder Area
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THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

 

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhances genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

 
POSITION SUMMARY:
The Senior Risk Management Design Quality Engineer will support risk management across the product life cycle, leading safety risk management deliverables, interfacing with product development teams, manufacturing, post market monitoring, regulatory and clinical operations. Will be responsible for managing, authoring, organizing, and supporting risk management compliance to insure goals and objectives are being met. This position will serve as a subject matter expert on Archer’s risk based design lifecycle for software, system and assay. This position is expected to implement, collaborate, lead, interface and author risk management quality documentation.
 
RESPONSIBILITIES:
As part of design & development, the person in this role will need to be hands on working with FTA, PHA, uFMEA, dFMEA, sFMEA, pFMEA and cybersecurity risk assessments. Risk management will also need to be performed as part of post market monitoring in support of complaint risk analysis, field corrective actions, design changes, maintenance efforts, non-product software risk assessments, supplier risk assessment evaluation and manufacturing non-conforming materials. This person will need to be well versed with medical device FDA and EU regulations, and all the necessary steps for risk management documentation.
 
Longer term improvement opportunities for the organization will be to centralize and improve the risk analysis documentation and completion efficiency such as selecting, deploying and configuring risk management tools. 
This person will need to develop clinical knowledge in IVD assay systems and supporting medical device software used to perform clinical analysis. These efforts will require leading and applying a consistent approach to hazardous situations, harm identification and risk estimation in order to ensure uniformity within each project life cycle. These may entail working with clinical experts, external business partners, and chief medical officers.
 
Daily tasks for this role will be based around risk management documentation, risk analysis, failure mode effects and analysis, authoring risk controls and traceability mapping for identified risk controls including their verification of effectiveness, risk based V&V methods and post market software maintenance, residual risk review and risk benefit analysis. Product DHF risk management files shall be organized in order to support successful regulatory submission when working with the regulatory teams for FDA and EU submission.
 
Partner with other functions in the organization to ensure stakeholders requirements are addressed, provide consistent communication with cross functional teams and encourage a spirit of risk management collaboration throughout the organization. Applies flexible and novel approach to solve problems or optimize solutions in complex or cross functional product development and manufacturing.
Support risk management audits, as a subject matter expert, when working with external business partners and regulatory authorities. When assigned findings for closure, demonstrate accountability and a commitment to continuous improvement by resolving issues.
Perform other duties as assigned by supervisor
 
QUALIFICATIONS:
  • Minimum of 5 years in supporting risk management used in a regulated industry with desired experience in performing software risk assessment. Good technical writing skills with hands-on experience authoring, peer-reviewing and defending risk management documentation.
  • Ability to speak and defend risk management 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.
  • Design quality risk management subject matter expert in the implementation and compliance with 21 CFR 820.30 ISO 14971, ISO 13485. 
  • Desired experience and knowledge with IEC 62304, MDR, IVDR, TIR57, FDA cybersecurity guidance, HIPAA, GDPR.
 
EDUCATION:
Minimum B.A. or B.S., preferably in engineering or other technical discipline
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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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