Engineer 2, Design Assurance

Engineer 2, Design Assurance - This position will be based in our Minnetonka, MN site.

Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below.

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. Join us as an Engineer 2, Design Assurance 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, Design Assurance 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 Design Assurance 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
• Lead DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Support print specification definitions, development, and changes
• Support design test and inspection method development and validation
• Support 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.

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.

The most likely base pay range for this position is $67K to $101K 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.

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