Senior Systems Engineer Radiology Research and Early Development

About the role

Design & develop new medical device products in accordance with customer needs and technical and regulatory requirements. Support new product development programs from early development to launch. Identify requirements. Analyze & design system architectures. Perform hazard analysis & mitigation. Guide hardware & software design direction. Work with cross-functional teams.

Responsibilities

• Performing new product medical device and/or combination product design
• Creating & maintaining DHF documentation throughout design control process
• Developing verification & validation activities to meet patient, customer, and regulatory requirements
• Creating pre-submission content & presenting to US FDA in Type-C & Pre-Submission meetings
• Applying FDA, NRC, DOT, ICRP and IAEA regulations pertaining to radioactive material use
• Applying AAMI TIR 101, Total Product Life Cycle Guidance for Infusion Pumps to design & testing of infusion systems
• Developing test protocols and/or microbiological methods to identify sources for microbial contamination & performing required V&V testing

Requirements

Master’s in Biomedical, Systems or Mechanical Engineering or closely-related technical field & 2 yrs experience in medical device design and/or engineering position(s): performing new product medical device and/or combination product design; creating & maintaining DHF documentation throughout design control process; developing verification & validation activities to meet patient, customer, and regulatory requirements; creating pre-submission content & presenting to US FDA in Type-C & Pre-Submission meetings; applying FDA, NRC, DOT, ICRP and IAEA regulations pertaining to radioactive material use; applying AAMI TIR 101, Total Product Life Cycle Guidance for Infusion Pumps to design & testing of infusion systems; and developing test protocols and/or microbiological methods to identify sources for microbial contamination & performing required V&V testing.

Qualifications

Employees can expect to be paid a salary between $110,000.00 to $130,000.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. The offered salary may vary within this range based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

Skills

Required: Master’s in Biomedical, Systems or Mechanical Engineering or closely-related technical field & 2 yrs experience in medical device design and/or engineering position(s).

Benefits

Health care, vision, dental, retirement, PTO, sick leave, etc.

Pay

$110,000.00 - $130,000.00

Schedule

Position may telecommute from home office location within reasonable commuting distance of Indianola, PA up to 1 day per wk. Up to 10% US travel req’d.

Contact Us

Creeve Coeur, MO
63167
bhc_careers@bayer.com

Division

Consumer Health

Reference Code

871945

Location

Indianola, PA

Employment Type

Regular

Position Grade

N/A

Equal Opportunity Employer Statement

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