OverviewPosition Summary:We are seeking a motivated and detail-oriented Process Engineer to join our On-Market Sustaining Engineering team. In this role, you will support both proactive and reactive product lifecycle initiatives, driving design enhancements, process improvements, and product reliability efforts. The ideal candidate is analytical, methodical, and collaborative, with the ability to thrive in a fast-paced, cross-functional environment. Working within established engineering procedures, you will contribute to reliability and continuous improvement projects while partnering closely with R&D, Manufacturing, and Quality teams.
Under the guidance of senior engineering personnel, you will be responsible for conducting root cause investigations, collecting and analyzing data, developing and implementing corrective solutions, and supporting validation activities. Key focus areas include data analysis and presentation, problem-solving, validation protocol development and execution, and driving sustainable improvements to products and manufacturing processes throughout the product lifecycle.
The annual base salary range for this role is currently $90,000 to $120,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.
ResponsibilitiesKey AccountabilitiesEssential Functions:- Acts as an Individual contributor, core team or technical lead for a specific project or product line.
- Accountable for the completion of assigned deliverables in accordance with approved schedules.
- Authors documentation and participates in activities in support of design control.
- Independently plans, performs & prioritizes tasks that are complex in nature, in alignment with corporate goals.
- Analyzes and interprets data, identifying trends and formulating next steps
- Ability to present tradeoff analysis and provide sound recommendations based on technical assessment.
- Experience leading the development of test strategies, execution process validation, including: IQ, OQ, PQ, Guage R&R, DoE, process capability.
- Must have experience in design requirements and risk management (pFMEA), driving risk mitigation to closure in collaboration with cross-functional teams.
- Experience working with electromechanical assemblies and instrumentation and test fixtures.
- Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.
- Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.
- Responsible for estimating and planning validation activities across the development lifecycle
- Transition validated process to operations: provide training, procedures, and on-floor support
Secondary Functions:- May review and provide input to deliverables from other functions.
- Recommends and drives improvement initiatives and motivates others to implement.
- May be assigned CAPA ownership.
Internal Networking/Key RelationshipsTo be determined based on department needs, to include interactions such as:
- Will interface on a regular basis with groups across the organization as needed
Skills & Capabilities:- Statistical Analysis, Root Cause Analysis, Creative Problem Solving
- Technically adept and confident
- Leadership: Accountability, Decision Making, Communication
QualificationsMinimum Knowledge & Experience Required for the Position:Education:
- Bachelor's degree in Engineering, Science or a related field
Experience: - Five years of product development or relevant experience
- One to three years of product development or relevant experience for advanced degrees
- For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
- In vitro medical device experience highly desired.
Additional Skills/Knowledge:- Language: Proficiency in English language required
International Mobility:Travel Requirements:- Some domestic and international travel may be required.
ClosingIf you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.