Senior Engineer (Contractor)
Diversity & Inclusion
Location: Saint Paul
Posted on: April 3, 2021
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
- Develop and commercialize devices using structured product
- 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
- 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
- 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
- Utilize electronic document archive system and collaborate with
Document Control team to ensure document compliance with PQS
standards and DHF regulations. Qualifications Education and
- 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
- 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,
- Full data and statistical analysis (JMP, Minitab) and Design of
- 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 .
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
Didn't find what you're looking for? Search again!