Senior Engineer 1, Quality Engineering

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Senior Engineer 1, Quality Engineering

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 Senior Engineer 1, 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 Senior Engineer 1, 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.This position is also responsible for quality engineering activities to support design changes for commercial products. Through these activities, the Senior Engineer 1, Quality Engineering will verify the quality, reliability, and compliance of mechanical product designs.

In this role, you'll have the opportunity to:

• Drives mechanical product design quality, reliability, and compliance to standards and regulations. Leads and supports on-time completion of design control deliverables

• Critically evaluates mechanical product designs, identifies potential design quality issues, and drives issue resolution

• Leads preparation of risk management files and reports for product releases, and has primary responsibility for risk management activities from product conception through commercialization

• Develops release testing plans for new products

• Leads DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

• Supports: Quality system development and improvements; print specification definitions, development, and changes; design test and inspection method development and validation; design verification/validation and reliability study execution and deliverables; ensures compliance with quality system regulations; manufacturing process development & qualification for new product commercialization and product changes

• Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements, as well as on-time execution of Quality Plans for OEM manufacturing for development projects and design changes

• Supports internal & external audits, complaint investigations, and significant investigations related to product quality for commercial products as needed

To succeed in this role, you'll need:

• Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science

• 5+ years relevant experience within the medical device industry or related function

• An equivalent combination of experience and education may be considered

• Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance preferred

• Ability to educate stakeholders, customers, suppliers, and management and experience with participation in audits

• Design for Six Sigma and Critical to Quality training and experience preferred

• Background in sterile pharmaceutical products and drug-device combination products related to development and commercial programs preferred

• ASQ certification preferred

In return, we offer you:

• 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 $88,000 - $123,000 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.

AccessibilityandReasonableAccommodations:
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 hrbox@halozyme.com.

To view all our open positions, please visit our career page. Additionally, our benefit offerings can be found here.