Kyyba

Spec 3, Engineering Program/Project Mgmt

Posted on: 14 Apr 2021

San Diego, CA

Job Description

Job Description

Job Description
Looking for Program Manager to support large New Product Development program.
Familiarity with product development of high volume disposable medical devices strongly preferred.
Same for work experience in production ramp-up and market introductions.

Drive the development of new medical device development programs through project completion within timeline, quality and budgetary limits
Lead and integrate cross-functional teams and manage deliverables and decision making in a matrix organization
Lead, manage and direct the development and execution of integrated project plans relevant to the deliverables and ensure alignment across relevant functions and a smooth transition among pipeline stages
Manage multiple projects across several departments while influencing project decisions in coordination with Marketing, Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics
Identify and implement solutions to improve tracking, planning and collaboration
Ability to gain cooperation of others and effectively facilitates cross-functional meetings and discussions
Ensure effective, accurate and timely communication across functional areas and matrix
Serve as a primary point of contact for management regarding progress and goals
Work with the functional leaders to identify and resolve any team and individual performance issues
Bring a broadened business perspective to each project through an understanding of the inner-workings of Marketing, Quality, R&D, Finance, Regulatory, Manufacturing, Clinical, Medical Affairs, and Operations

Minimum Qualifications:

A minimum of a Bachelor's degree
A minimum of 5-7 years of Project Management experience
A minimum of 13+ years related work experience in product development.
Demonstrated success in several large Project/Program Management roles including Development and Deployment, preferably healthcare, or closely related is a plus
Experience leading large global programs with distributed teams and leadership
Excellent interpersonal, communication, presentation and influencing skills
Ability and willingness to travel occasionally.

Preferred Qualifications:

PMP certification
High volume device and/or drug development and project management within the medical device/pharmaceutical industry, or reasonable combination of the two
Strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the product development process
Experience with short release cycles
Experience managing ambiguity and providing clarity for teams
Experience working in a highly government-regulated environment (FDA, MDR).
Must have led a cross-functional project team through regulatory submission and product commercialization
Demonstrated learning agility of new subject matter
Demonstrated application of product development and project management best practices on recent programs
Experience working in a highly government-regulated environment (FDA, MDR).
Must have led a cross-functional project team through regulatory submission and product commercialization

Not looking for an IT or Finance PM. Prefer candidates that are local, project position. Open to direct report working remote, however prefer onsite.
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client

SELECT AWARDS

* An INC 5000 company for 10 years
* Corp! Michigan Economic Bright Spots
* Crain's Detroit Business Top Staffing Service Companies in Detroit
* TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
* Best of MichBusiness winner in HR Wizards & Partnerships
* Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
* 101 Best & Brightest Companies to Work for in Michigan

Kyyba

Farmington Hills, MI

Kyyba is a privately held company and specializes in staff augmentation, application software and project solutions. In operation for more than 20 years, we have earned an enviable track record and reputation within all the industries we serve. Our unique processes and maturity enable us to understand the needs of the business organizations and provide business solutions that match the real and compelling needs of our customers.

Headquartered in Michigan, Kyyba has multiple office locations and we serve local, regional and national client base consisting of Fortune 500 and middle market companies. Kyyba extends the above solutions and services to a broad spectrum of industry verticals ranging from automotive, insurance, technology, financial, transportation, government and so on.

Kyyba has been an Inc. 5000 recipient for Fastest Growing Private Company for nine years, most recently in 2017.