Coordinate the development and validation of components and assembly processes.
Collaborate with multi-functional partners for supplier selection, project and product risk management, and design & process transfer to manufacturing site(s).
Organize DFM/A inputs and enable translation of product design inputs to product and process outputs.
Provide departmental technical expertise and collaborate with research and development, product management, stability, regulatory, and quality process among other functions to ensure all design requirements are met.
Deliver full-scale production solutions from concept to stable production.
Lead resolution of related issues in manufacturing, compliance, and the field.
Promote and champion the highest standards of integrity, ethics, and compliance and actively supports our compliance program-related initiatives and activities.

Requirements

Bachelor’s degree in engineering or related technical degree; Advanced degree or equivalent experience preferred.
6+ years of experience in manufacturing process development in a regulated industry.
Experience in leading complex, multi-functional projects with a focus on innovation and operational excellence.
Experience as a process engineer with a strong understanding of product component and assembly manufacturing processes.
Applied statistical analysis techniques (Process Stability / Control / Capability methods, Measurement Systems Analyses).
Previous experience with Design for Manufacturing & Assembly (DFMA) and Failure Mode Effects Analysis (FMEA).
Excellent communication, networking, teamwork, problem solving, and influencing skills.
Preferred: Experience with commercialization of products in a regulated industry.
Led equipment debug, characterization, FAT, and qualification activities.
Understanding of sterilization modes used in medical devices.
Familiarity with Lean and Six Sigma/Process Excellence and/or Project Management/PMP/FPX methodologies.
Experience working in a global or multinational organization.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

manufacturing process developmentstatistical analysis techniquesDesign for Manufacturing & Assembly (DFMA)Failure Mode Effects Analysis (FMEA)process stabilityprocess controlprocess capability methodsequipment debugcharacterizationqualification activities

Soft Skills

communicationnetworkingteamworkproblem solvinginfluencingleadershipcollaborationproject managementinnovationoperational excellence

Certifications

Bachelor’s degree in engineeringAdvanced degree or equivalent experiencePMP certification