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Engineer 2, Quality Engineering-This position will be based in our Minnetonka, MN site.
Welcome to an inspired career!
At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.
Join us as a Engineer 2, Quality Engineering and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.
How you will make an impact
The Engineer 2, Quality Engineering leads quality engineering activities for development projects from conception to commercialization, including development of the risk management file, completion of DHF deliverables, and significant involvement in design verification/validation. In this role, you will support quality engineering activities for design changes for commercial products. Through these activities, the Quality Engineer verifies the quality, reliability, and compliance of mechanical product designs.
In this role, you’ll have the opportunity to:
- Drive mechanical product design quality, reliability, and compliance with standards and regulations
- Lead and support on-time completion of design control deliverables
- Critically evaluate mechanical product designs, identify potential design quality issues, and drive issue resolution
- Lead preparation of risk management files and reports for product releases, and have primary responsibility for risk management activities from product conception through commercialization
- Develop release testing plans for new products
- Leads DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- Supports print specification definitions, development, and changes
- Supports design test and inspection method development and validation
- Supports design verification/validation and reliability study execution and deliverables; ensures compliance with quality system regulations
To succeed in this role, you’ll need:
- Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science with a minimum of 2 years relevant experience within the medical device industry or related function (a combination of education and experience may be considered)
- Strong statistical data analysis skills
- Design for Six Sigma and Critical to Quality training and experience
- Background in sterile pharmaceutical products and drug-device combination products related to development and commercial programs
- Experience partnering with external organizations (customers and suppliers) to complete projects
- Experience with participation in audits
- Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred
- ASQ certification preferred
In return, we offer you:
- Hybrid work flexibility-requires 3 days weekly to work on site and more as needed
- Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching
- Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement
- A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.
The most likely base pay range for this position is $71K to $100K per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.
Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Accessibility and Reasonable Accommodations:
Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at [email protected].
To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here.
What We Do
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the company's partners make progress developing and commercializing their products being developed with ENHANZE®.
We are a diverse team, who are committed to bringing therapies and results to patients. It's not enough to be qualified and experienced at what you do, we are looking for people who believe in our mission and match our values.
We are building a company where people can pursue their career goals in a supportive and collaborative team environment. Visit www.halozyme.com/careers for more details.
We are Halozyme.
