Kelly Services Product Lifecycle Engineer in Lakewood, Colorado
Product Lifecycle Engineer, Disposables
Salary Range: $95K - $100K plus bonus
Location: Lakewood CO
Duration: Direct Hire
Kelly Services is seeking a Product Lifecycle Engineer that will provide cross functional, influential leadership and product subject matter expertise to the company over the life cycle of the product(s) assigned.
Acts as the subject matter expert on assigned Disposables product line(s) over the life cycle of the product.
Reviews and approves product documentation that may include design reviews, verifications, lower level requirements, and product specifications, as applicable.
Consult and advise on product changes through design control processes and change control processes including: design change implementation, production quality issues, field quality issues, production process changes, regulatory filings/registrations, supplier quality changes.
Advise on content for systems product documentation including: Product Requirements, System Architecture, User and Environmental Analysis, and Risk Management
May contribute guidance for standards for product testing and testing procedures; ensures consistency across product lines where applicable by partnering with other SMEs.
Reviews and updates Technical File for assigned product(s), and understands applicability of required standards.
Could perform product training for other associates
May utilize hands on time with the products and platform to maintain product knowledge or train other associates
Working knowledge of cross-functional and related technical areas (such as Quality, Manufacturing and Regulatory).
Advises team members pro-actively on technical ideas and product knowledge and promotes development of team work and product knowledge.
Participates in inter-organizational and outside customer contacts as needed.
Represents the organization in providing solutions to difficult technical issues associated with specific product(s) and projects.
Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
Presents complex technical information and analysis, and responds effectively to questions from technical staff members and management, as needed.
Displays accessibility and sought out for consultation on a broad range of complex technical and industry issues by engineering staff and management.
OTHER DUTIES AND RESPONSIBILITIES
Work direction responsibility may include technicians and junior engineers.
May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
Must consult or collaborate with Product Lifecycle Engineers for interfacing equipment.
MINIMUM QUALIFICATION REQUIREMENTS
Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Bachelor of Science Degree in Engineering is preferred.
Minimum 4 years’ experience.
Two years of GMP manufacturing experience required.
Experience in medical device, pharmaceutical, or other regulated industry.
Demonstrated interactive skills in, cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
Represents the organization as the prime technical contact on products. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
Follows and consults in the development of technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
Exhibits strong managerial courage both technically and personally
Requires demonstrated skills in technical innovation, technical leadership, mechanical or chemical engineering, fluids engineering, and cellular biology.
Exhibits strong technical problem-solving skills.
Understands and adheres to GMP practices and FDA regulations.
Possesses knowledge and ability to implement FDA or other regulatory requirements as necessary.
Demonstrated ability to communicate effectively both verbally and in writing.
Possesses knowledge and use of relevant PC software applications and skills to use them effectively.
Ability to train other associates on product(s) function, use, risks, and differentiation in the market.
Possesses natural inquisitiveness. Willing to question to understand why, what and how.
Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
Possesses skills necessary for potential interactions with customers
Qualified candidates should email resume and references for consideration.
Kelly Services, Inc. is an Equal Opportunity Employer.
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
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.