1+ months

Systems Engineer

Kelly Services
Rockville, MD 20851
**Systems Engineer**

**Location** : Rockville, MD [100% on-site]

**Type** : Full-Time, Direct Hire


+ Using Design Controls to facilitate the design and development of next-generation (portable, distributable and end-to-end continuous process) pharmaceutical manufacturing system, for drug substance and drug product.

+ Lead Risk Management within Engineering function, interfacing with stakeholder from other functions, i.e. analytical development, formulation development, manufacturing, GMP Ops and QARA.

+ Conduct Requirements Identification, Development and Analysis:

+ Capture User Requirements via Use Case Development and Activity Modeling,

+ Translate business objectives into system level requirements

+ Facilitate analysis and trade-off studies to balance requirements against technical and cost feasibility

+ Conduct Requirements Management:

+ Manage the evolution of requirements through baselines and requirements traceability matrixes (RTM)

+ Working with cross-functional teams, develop and publish specifications

+ Facilitate Functional Analysis, including translating user needs from chemical or formulation processes (process parameters) into system requirements

+ Support development of test plans and verification procedures

+ Model activities, sequences/ interactions, and system/operational states to capture & analyze requirements

**Minimum Hiring Standards:**

+ Bachelors degree in engineering, mathematics or other STEM major

+ 5 to 10 years of related systems engineering experience

+ Experience in medical device or pharmaceutical industry

+ Hands on experience with Design Controls, ISO 13485 and Risk Management, ISO 14971

+ Experience in DFMEA/FMEA, Six Sigma, and Risk Management

+ Experience in Requirements Management Software, Jama Connect preferred

+ Experience with medical device or pharmaceuticals manufacturing development

+ Experience in project management

+ Strong management and interpersonal skills

+ Ability to work collaboratively with multi-disciplinary cross-functional research teams

+ Strong written/oral skills required, and ability to communicate technical concepts to a non-technical audience

**Preferred Hiring Standards:**

+ Masters degree in Systems Engineering or related field

+ Individuals with > 5 years experience and training preferred

**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: 2022-02-21 Expires: 2022-05-23

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Systems Engineer

Kelly Services
Rockville, MD 20851

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