Program Manager

Job title: Senior Principal Engineer, Manufacturing

Contract Period: 12 Months

Location: Round Lake, IL

This role will provide External Contract Manufacturing (ECM) and technical leadership for major, high- complexity programs (e.g., Top Projects) within the Medication Delivery Global Business Unit, leading Product teams through the planning, prioritization, development, implementation, and maintenance of ECM’s Device Master Records (DMR).

They will collaborate with Supplier Quality, Program Management, R&D, Labeling Group, Marketing, Product Quality, etc. to own the development and maintenance of ECM associated documents within their respective DMRs.

The Senior Principal Engineer, Manufacturing, will interact with and influence internal and external stakeholders and core team members.

They will manage stakeholder commitments and expectations with regard to program deliverables during the remediation program.

Essential Duties and Responsibilities: The incumbent will perform other duties assigned. Accountable for performance, program schedule and execution, budget commitments and spend. Leads team in defining program strategies for ECM’s DMR remediation activities, establishing, and achieving defined goals.

Interacts through routine updates and project reviews with all functions and levels of management, ensuring effective ongoing communication across teams and stakeholders.

Ensures identification and communication of program/project risks, development of risk mitigation plan and proactive management of risk response strategies.

Anticipates potential ECM conflict situations and applies proactive solutions to result in win-win.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Skills:

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Prefer experience with TQM methods (e.g., six sigma), display a solid technical understanding and application of engineering principles. Must have experience or advanced training and demonstrate proficiency (e.g., design controls, change control, problem analysis and resolution, manufacturing processes, manufacturing controls, process validations).

Completely proficient in medical devices and associated process development processes. Knowledgeable in aspects of Medical Device Manufacturing, Design Controls (Verification, and Validation) to comply with international medical device regulatory requirements.

Must be able to quickly grasp understanding of ECM processes, associated product impact and Quality processes to adequately assess project risk and challenge planning content.

Successful track record of managing wide-ranging activities within a business unit and demonstrates leadership skills, business acumen (role model of Vital Behaviors and Leadership Essentials).

Recognized as a technical expert on Medical Device Manufacturing, while understanding Good Manufacturing Practices, Good Laboratory or Clinical Practices and Product Development Process requirements.

Demonstrated success in delivering results on several technical challenges, including extensive cross-functional team experience. Ability to organize and present technical and project overviews without assistance, knowledgeable in aspects of Program Management.

B.S. degree in Industrial Engineering, Manufacturing/Process Engineering, Medical Device

Development discipline with 8-10 years of experience. and in Facility System and Equipment

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, we’re here every step of the way to find your dream engineering job.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.