1+ months

Sr. Medical Device Engineer

Kelly Services
South San Francisco, CA 94080
Kelly Services is currently seeking **Senior Medical Device Engineer** **for** one of our top clients in **South San Francisco, CA**

**JOB TITLE: Senior** **Medical Device Engineer**

**INDUSTRY:** BioPharmaceutical

**WORK LOCATION: S** **outh San Francisco, CA**

**DURATION:** 12 Months (Temporary / Contract)


The parenteral device development group is responsible for design and development of combination products and medical devices to bring our life changing medicines to patients. In this role, you will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects based on a robust understanding of engineering fundamentals, the product requirements, and business needs. You will be responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, primary container design, component selection, manufacturability and testing specifications and methods meet product needs.

You must effectively collaborate with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development. Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders.

**Main Duties & Responsibilities:**

- Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of primary containers and/or drug delivery devices for the pipeline

- Leads or participates in technically demanding projects within specific area or field of Subject Matter expert. Applies engineering principles for the design and development of robust devices/methods/processes that meet patient, molecule and business needs.

- Strong technical capability in solving complex problems using tools such as: mechanistic and statistical modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, usability engineering tools, design for manufacturability/assembly techniques and design for six sigma

- Contribute to departmental combination product and primary container development capability by applying and maintaining a high level of knowledge and expertise

- Strong knowledge of regulations and standards such as design controls, risk management, human factors and industry standards specific to an individuals subject area (e.g. risk management, Design Controls, FDA QSR, ISO13485, ISO standards etc.)

- Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations

- Drive a Quality approach and ensure that work is performed in accordance with appropriate quality requirements and compliance to standards

- Contribute to regulatory filings and health authority responses

- Develop and implement best practices / business processes

**Education & Experience Requirements:**

- Education: BS and 10 plus or MS and 8 plus or PhD and 0 years of experience.

- Experience: 8-12 years of experience in technical roles within combination product and/or primary container development, depending on the highest level of education completed and the level of applicable expertise.

**Required Skills:**

- Excellent leadership skills

- Ability to lead a cross functional team and ensure success of the project.

- Experience in working with external development and commercialization partners and suppliers is highly desirable.

A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.

- Excellent communication skills are required.

- Familiarity with industry standards and practices applicable to primary container, device and/or combination product development is required.

**Desired Skills:**

- Substantial post graduate experience in combination product & device/process development

**Why Kelly?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*

Let us help advance your career today.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2022-05-18 Expires: 2022-07-18

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Sr. Medical Device Engineer

Kelly Services
South San Francisco, CA 94080

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