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Senior Engineer (Contractor)
Diversity & Inclusion

Company: Genentech
Location: Saint Paul
Posted on: April 3, 2021

Job Description:

PLEASE NOTE: Preferred location for this role is Minneapolis / St. Paul, MN. The Senior Device Engineer will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech. The candidate has technical expertise in the development and commercialization of drug device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within Genentech's device development programs, including manual injection systems, automated injection systems, and high speed assembly processes. The Senior Device Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members. The work is reviewed with a focus on long-term perspectives, as the Senior Engineer establishes his/her own work priorities and timelines. Job Responsibilities The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.-- This objective will be accomplished by executing activities in the areas of:

  • Develop and commercialize devices using structured product development process.
  • Provide guidance and input regarding product development.
  • Regularly interface with staff and leaders in Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs.
  • Regularly interact with external development partners and components suppliers.
  • Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.
  • Write and execute Design Verification protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods. Quality Systems Compliance:
    • Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
    • Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
    • Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
    • Create and review discrepancy, change and risk management documents for Devices Teams, as appropriate.
    • Ensure compliance of training to PQS and job-related requirements. Design Control:
      • Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
      • Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
      • Participate in hazards analyses and design assessments and reviews.
      • Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations. Qualifications Education and Industry Experience:
        • B.S, M.S, Ph.D. or advanced degree in Engineering, with preferences for Mechanical Engineering or equivalent.
        • At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
        • Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on DOE, problem solving and modelling using physical rules. Technical Knowledge: Strong skills in relevant modeling, design controls and/or statistical analysis. For example:
          • Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, Molding.
          • Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
          • Design Controls for regulatory compliance & filing (ISO 13485, etc.): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
          • Six Sigma (Green/Black Belt): DMAIC and DFSS.
          • Human Factors Evaluations: User needs research, Usability engineering and associated risk analyses. Interpersonal Skills:
            • Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.
            • Excellent communication skills are required. Experience in working with external partners is also highly desirable.
            • Highly organized and detail oriented.
            • Excellent leadership skills.
            • Ability to work/visit vendors in the Minneapolis/ St Paul area This is a temporary assignment. The individual in this role will be employed by a third party, not by Genentech Roche is an equal opportunity employer. #LI-LL1 Who We Are Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work. The next step is yours. To apply today, click on the "Apply for this job" button. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page .
              • Minneapolis
                Minnesota, United States of America
              • St. Paul
                Minnesota, United States of America

Keywords: Genentech, St. Paul , Senior Engineer (Contractor)
Diversity & Inclusion, Engineering , Saint Paul, Minnesota

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