Program Manager – Material Regulations & Biocompatibility Database

Waukesha, WI - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

The Program Manager will be a key member of a global cross-functional team responsible for transforming the way product material composition data is managed across GE Healthcare products. This role will also lead the development of a comprehensive biocompatibility database to streamline external testing and ensure regulatory compliance. The Program Manager will establish lean standardized processes for collecting and managing material substance information from diverse systems as well as biocompatibility test data. This centralized approach will enable accurate product content reporting for tender requests and provide the necessary documentation to meet regulatory requirements. The Program Manager will work with all relevant stakeholders across all functions of the organization.

Job Description

Roles and Responsibilities

Lead a global initiative to collect organize and maintain product material information and biocompatibility test results
Develop and deliver lean standardized documentation guidance and training for material composition and biocompatibility testing in GE Healthcare medical devices
Implement automation for supplier data collection
Collaborate with Sourcing to establish common standardized practices across all suppliers
Align engineering part attribute data with supplier provided information
Define and enforce standard documentation requirements
Drive adoption of standardized process across product sub-segments
Monitor consolidate and report overall program progress and status

Qualifications

Bachelors Degree in a technical field (e.g. EE ME) and/or 10 years relevant product development experience
Strong subject matter expertise in data analytics for engineering and business tools
Knowledge of supply chain principles and experience working with material suppliers or sourcing functions
Knowledge of ISO 17025 quality system standard
Ability to create long lasting relationships with stakeholders building trust through effective communication and strong interpersonal connections
Strong influencing skills to manage conflicts/unforeseen events
Knowledge of trade associations and standards development groups involving environmentally conscious design and regulations

Desired Characteristics

10 years of relevant engineering manufacturing quality or product compliance experience
5 years of expertise with environmentally conscious design and/or sustainability programs
Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document plan market and execute programs. Established project management skills.
Experience working in a highly regulated industry preferably with time spent directly in product development certification testing lab accreditation and global market entry requirements
Knowledge of materials and chemical substances found in parts & components
Strong subject matter expertise in environmentally conscious design standards and regulations impacting the broad GEHC product portfolio
Knowledge of AI tools associated with data management
Familiarity with the broad GEHC product portfolio and demonstrated cross-functional and multi-product knowledge
Proven ability to work cross-functionally and with global virtual teams
Passion for people development and willingness to take risks
Proven mentoring and coaching abilities; demonstrated ability to motivate & inspire others
Demonstrated ability to deliver results while working on multiple projects simultaneously balancing resources timing and quality of outcomes

We will not sponsor individuals for employment visas now or in the future for this job opening.

GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer . Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: Yes

Required Experience:

Manager

Job Description SummaryThe Program Manager will be a key member of a global cross-functional team responsible for transforming the way product material composition data is managed across GE Healthcare products. This role will also lead the development of a comprehensive biocompatibility database to ...

Job Description Summary

Job Description

Roles and Responsibilities

Lead a global initiative to collect organize and maintain product material information and biocompatibility test results
Develop and deliver lean standardized documentation guidance and training for material composition and biocompatibility testing in GE Healthcare medical devices
Implement automation for supplier data collection
Collaborate with Sourcing to establish common standardized practices across all suppliers
Align engineering part attribute data with supplier provided information
Define and enforce standard documentation requirements
Drive adoption of standardized process across product sub-segments
Monitor consolidate and report overall program progress and status

Qualifications

Bachelors Degree in a technical field (e.g. EE ME) and/or 10 years relevant product development experience
Strong subject matter expertise in data analytics for engineering and business tools
Knowledge of supply chain principles and experience working with material suppliers or sourcing functions
Knowledge of ISO 17025 quality system standard
Ability to create long lasting relationships with stakeholders building trust through effective communication and strong interpersonal connections
Strong influencing skills to manage conflicts/unforeseen events
Knowledge of trade associations and standards development groups involving environmentally conscious design and regulations

Desired Characteristics

10 years of relevant engineering manufacturing quality or product compliance experience
5 years of expertise with environmentally conscious design and/or sustainability programs
Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document plan market and execute programs. Established project management skills.
Experience working in a highly regulated industry preferably with time spent directly in product development certification testing lab accreditation and global market entry requirements
Knowledge of materials and chemical substances found in parts & components
Strong subject matter expertise in environmentally conscious design standards and regulations impacting the broad GEHC product portfolio
Knowledge of AI tools associated with data management
Familiarity with the broad GEHC product portfolio and demonstrated cross-functional and multi-product knowledge
Proven ability to work cross-functionally and with global virtual teams
Passion for people development and willingness to take risks
Proven mentoring and coaching abilities; demonstrated ability to motivate & inspire others
Demonstrated ability to deliver results while working on multiple projects simultaneously balancing resources timing and quality of outcomes