Design Quality Engineer
Namocell
By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$73,100.00 - $120,200.00Position Summary:
The Design Quality Engineer supports the qualification and validation of new products and product modifications, new equipment builds and modifications to existing equipment for the purpose of ensuring manufacturing goals of producing quality products, efficiently and repeatedly are met. The Design Quality Engineer must apply part 21 CFR 820 guidance, cGMP and applicable ISO standards during design & development and verification & validation activities. This position closely collaborates with the Engineering, Manufacturing, Manufacturing Engineering, Purchasing and Quality Control departments.
Key Responsibilities:
Support Engineering in creating design & development documentation for new/modified products, equipment, and systems.
Responsible for product, equipment, and process risk assessments, FMEAs, fault-tree analysis, risk management plans.
Collaborate with engineering to create requirement specification documents for manufacturing equipment and systems.
Creates and executes equipment and system qualification and validation protocols.
Collaborates with other quality engineers and design staff to determine best validation practices.
Recommends design or test methods and statistical sampling plans for achieving required levels of product and process reliability.
Compiles and analyzes performance reports and process control statistics; works with engineering to investigate and analyze relevant variables potentially affecting product and processes.
Brainstorms new and innovative ways to increase production efficiency.
Communicates clearly and effectively with others.
Translates technical engineering language to layman’s terms for the purposes of presentations.
Demonstrates ability to use measurement tools and machinery.
Follows company policies and practices as outlined in the Handbook, SOPs and SWIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance with the job function.
Support internal and external quality auditing activities.
Other duties as assigned.
Education and Experience:
A Bachelor’s degree in Mechanical, Electrical or Computer Engineering/Technology or related field.
3 – 5 years Engineering or Quality experience working in the quality, engineering or manufacturing departments companies producing In Vitro Diagnostics (IVDs), Medical Devices, or Pharmaceutical products.
Demonstrated knowledge of design & development concepts, verification & validation concepts, processes, scale-up, transfer, problem-solving, trouble-shooting, and experimental design.
Technical excellence specific to equipment automation and process validation.
Must have strong communication skills, both verbal and in writing and possess a working knowledge of analytical and process equipment, quality control systems and statistical software.
Must have strong organizational skills.
The ability to work in a collaborative way as part of a team is a must.
Basic mechanical aptitude and a good working knowledge of mechanical and optical manufacturing equipment is desired.
Working knowledge of ISO 13485
Proficient in Microsoft Office.
Why Join Bio-Techne:
We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne is an E-Verify Employer in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.