Principal Process Engineer

Job TitleWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.Position SummaryUsing Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Plans and conducts work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments and related fields. Generally, uses advanced techniques and the modification or extension of theories, concepts and practices in the specialty and/or related disciplines. Maintains a clear overview of a major product development. Makes sound judgments when compromises, necessitated by available time and technical capacity, must be made to meet set objectives. Mentors junior staff.The annual base salary range for this role is currently $150,000 to $165,000. 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.Key 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 the next steps, while effectively performing trade off analysis, if required by the function.Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for complex components and functions.Experience leading the development of test strategies, execution process validation, including but not limited to: 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.Evaluates complex designs or processes, with respect to acceptability, suitability and cost. Recommends preferred design options. Presents trade-off, if required by the function.Identifies product defects and able to recognize outliers in results. Able to explain and document product defects and their impact.Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.Leads without authority & provides technical guidance to engineers and technicians assigned to him/her on a given project. Provides mentoring within or outside of their department.Provides technical support for or leads CAPA or complaint investigations.Partner with Quality Engineering and Regulatory teams to support phase planning readiness and contribute to the Design History File (DHF)Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.Responsible for estimating and planning validation activities across the development lifecycleTransition validated process to operations: provide training, procedures, and on-floor supportSecondary 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.Budget Managed: (if applicable)N/AInternal Networking/Key Relationships:To be determined based on department needs, to include interactions such as:Will interface on a regular basis with groups across the organization as neededSkills & Capabilities:The ideal candidate for this position will exhibit the following skills and capabilities:Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical ThinkingTechnically adept and confidentLeadership: Accountability, Decision Making, Influence, CommunicationMentoringQualificationsMinimum Knowledge & Experience Required for the Position:Education:Bachelor's degree in Engineering, Science or a related fieldExperience:Twelve years of product development or relevant experienceEight to ten years of product development or relevant experience for advanced degreesFor internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experienceIn vitro medical device experience highly desiredAdditional Skills/Knowledge:Language: Proficiency in English language requiredInternational Mobility:Required: NoTravel 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.Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact View email address on click.appcast.io for assistance.