Assembly and Distribution Technician at Biodesix Inc

Louisville, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Aug, 26

Salary

20.0

Posted On

07 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Assembly, Distribution, FDA cGMP Regulations, Quality Documentation, Product Acceptance Testing, Inventory Management, KanBan System, Contamination Control, Microsoft Excel, Shipping, International Shipping, Medical Device Manufacturing

Industry

Hospitals and Health Care

Description

ABOUT US: Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs. Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics. For more information, please visit www.biodesix.com. [https://www.biodesix.com/] LOCATION & SCHEDULE: On-Site in Louisville, CO Monday - Friday 8AM to 4:30 PM OVERVIEW: The Assembly and Distribution Technician will work collaboratively with cross-functional teams to ensure the production of innovative diagnostic tests that meet FDA cGMP regulations and comply with the company's high standards of quality. The successful candidate will take ownership of initiating and completing quality documentation for kit builds, conduct product acceptance testing, maintain accurate inventory counts, and provide support for the efficient operation of the KanBan system for Manufacturing inventory. Additionally, the candidate will maintain a clean and organized work area, adhere to daily contamination controls, and respond quickly to environmental alerts. Finally, the candidate will be flexible and willing to take on other duties as assigned to support the success of the Manufacturing team. RESPONSIBILITIES: • Be a key player in the production of our innovative diagnostic tests • Ensure that quality kits are expertly assembled and comply with FDA cGMP regulations • Actively monitor and accurately input information into our Kit Order and Distribution System • Collaborate with cross-functional teams to fulfill kit orders and support our dedicated clinicians in improving patient outcomes • Take ownership of initiating and completing applicable quality documentation for kit builds • Play an essential role in prepping finished goods for distribution and ensuring they meet our high standards of quality • Conduct Product Acceptance Testing on batches of finished goods to ensure they meet our rigorous standards • Help maintain accurate inventory counts and support the efficient operation of our KanBan system for Manufacturing inventory • Maintain a clean and organized work area and adhere to daily contamination controls to ensure the safety of our products • Act quickly to monitor, respond to, and correct environmental alerts in a timely fashion REQUIREMENTS: • Strong organizational skills with exceptional attention to detail • Ability to read, write, understand, and clearly communicate in English • Proficiency in computer skills, including Excel, and e-mail systems • Ability to adapt to emerging situations and respond with a sense of urgency • Ability to consistently meet deadlines • Must adhere to all standard operation procedures within Quality Management System • Ability to train others on current processes • Shipping and International Shipping experience is a plus but not required • Medical Device Experience, preferred PHYSICAL REQUIREMENTS: • The physical demands described here are representative of those that must be met by a team member to successfully perform the essential functions of this job • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions • While performing the duties of this job, the team member is regularly required to use hands to grip, handle, or feel objects, tools, or controls and talk or hear • The team member is required to stand for up to 8 hours, walk, and reach with hands and arms; occasionally is required to stoop, kneel, crouch, or crawl, and must be able to lift and/or move more than 25 pounds • Specific vision abilities required by this job include visual acuity to Colorado driver’s license requirements EDUCATION AND EXPERIENCE: • High School diploma, required • Two or more years as an assembly technician in a high-volume manufacturing environment, preferred COMPENSATION: • Hourly Rate Starting at $20.00 • Discretionary Bonus opportunity • Comprehensive health coverage: Medical, Dental, and Vision • Insurance: Short/Long Term Disability and Life Insurance • Financial benefits: 401(k), Flex Spending Account • 120 hours of annual vacation • 72 hours of paid sick time off • 11 paid holidays + 3 floating holidays • Employee Assistance Program • Voluntary Benefits • Employee recognition program Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects. Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Responsibilities

The technician is responsible for assembling diagnostic test kits in compliance with FDA cGMP regulations and managing quality documentation. They also handle product acceptance testing, inventory counts, and the operation of the KanBan system.