Quality Assurance Mechanical Engineer

1 week ago


Hopkins, Minnesota, United States Antares Pharma Full time

At Halozyme, we are driven by a passion for innovation and a commitment to delivering exceptional patient experiences. Our team is seeking a skilled Quality Assurance Mechanical Engineer to join our Minnetonka, MN site. This role offers a unique opportunity to grow in a culture that prioritizes learning, development, and progression.

About the Role

We are looking for an experienced Mechanical Engineer to lead quality engineering activities for development projects from conception to commercialization. This includes developing risk management files, completing Design History File (DHF) deliverables, and participating in design verification/validation. In this role, you will support quality engineering activities for design changes for commercial products and verify the quality, reliability, and compliance of mechanical product designs.

Key Responsibilities

  • 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
  • Prepare risk management files and reports for product releases
  • Have primary responsibility for risk management activities from product conception through commercialization

Requirements

To succeed in this role, you'll need:

  • Bachelor's degree in Engineering (Mechanical, Material Science or Biomedical) or related Science
  • Minimum 2 years relevant experience within the medical device industry or related function
  • 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

We Offer

In return, we offer a hybrid work environment with flexibility, including 3 days per week on-site at our Minnetonka, MN site. We also provide a comprehensive benefit package, including an Employee Stock Purchase Program and 401(k) matching. Additionally, we prioritize learning and development opportunities through in-house programs and tuition reimbursement.

Compensation

The estimated base salary range for this position is $67K to $101K per year, depending on factors such as experience, tenure, skills, and business needs. Total compensation could include bonuses, sales incentives, and equity awards.



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