Program Manager - Quality

Position Summary

This role will support the research and development engineering team within ICU Medical s temperature management business unit.

This role will be supporting all R&D engineering aspects of the product development process and post market activities including both hardware and consumables products.

Completes advanced engineering projects with peer input and guidance from engineering management. This includes providing solutions to complex issues where analysis of designs or test data requires an in-depth engineering evaluation of variable factors pertaining to designs, methods, materials or processes.

The role is responsible for developing new design concepts and implementing design changes that affect system performance.

This role is also responsible for on-market support which may involve CAPAs, end-of-life issues, manufacturing issues and product / process cost reductions.

Work is highly independent and this role may assume a team lead role for the work group.

Essential Duties & Responsibilities

Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions.

Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design.

Develops specifications and requirements from customer requirements.

• Strong design and technical background in selection of engineering materials, plastic and metal components design, geometric dimensioning, and tolerance analysis (GD&T), critical to function (CTF), critical dimensions and tolerance stack-up analysis.
• Proficient in design Failure Mode Effects Analysis (dFMEA), Design for Assembly (DFA), Design for Manufacturability (DFM) and Design for Testability (DFT).

Identify any technical issues and schedule risks and define appropriate contingency plans.

• Receives general project direction. Responsible for project progress.
• Decisions consistently affect multiple or critical projects in the business and may impact external relationships.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.

Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus with their peers.

Manages training of new / current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.

May routinely monitor or supervise the work of one or more employees. May provides input on performance evaluations to area manager.

Work on special projects as they arise.

Knowledge, Skills & Qualifications

• Product development experience in the medical device industry and familiarity with IEC standards is preferred.
• Can assess what work supports the product strategy and make insightful recommendations regarding priorities
• Medical device or experience in a regulated industry preferred.
• Familiarity with Risk Management, Risk Documentation and developing dFMEAs
• Experience in CAPAs, Sustaining Engineering / On-Market product support
• Must have strong technical report writing skills.
• Solidworks experience preferred with knowledge of GD&T best practices.
• MiniTab and statistical experience preferred

Education and Experience, Minimum Qualifications

• Bachelor’s degree from an accredited college or university
• Mechanical or Biomedical Engineering degree preferred
• 7+ years’ experience
• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check

Travel Requirements

Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• On-site attendance 2-3 days per week
• This job will require the use of laboratory equipment
• Must be able to occasionally move and lift objects of up to 25 lbs
30+ days ago