Engineer, Product Sustaining (Finance)

Product Sustaining Engineer

SUMMARY:

The Product Sustaining Engineer will play a key role in the support, continuous improvement, and lifecycle sustainability of the CardioGen-82® Infusion System and its sterile disposable counterparts. This role, in collaboration with cross-functional teams, including Technical Operations, Quality, Regulatory Affairs and Third-party suppliers, involves analyzing, modifying, and enhancing the current design to improve performance, reliability, manufacturability, and compliance with evolving regulatory requirements. Responsibilities include leading and executing design modifications, failure analysis, root cause investigations, and product enhancements. This involves requirements assessment, engineering modeling and analysis, development of test methods and fixtures, and collaboration with suppliers to ensure high-quality, cost-effective solutions. Significant creativity and experience are essential for applying engineering principles to analyzing and verifying components, assemblies, mechanisms, and systems. The Sustaining Mechanical Engineer must be a self-starter capable of driving continuous improvement initiatives, addressing field and production issues, and collaborating with cross-functional teams to maintain and optimize product performance throughout its lifecycle.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Participate in the identification and execution of testing strategies in support of product development/improvement projects.
• Collaborate with vendors and contract manufacturers to ensure compliance with product specifications and quality standards. Provide technical support to non-routine (e.g. deviation, complaint) investigations to identify both root cause and remediation solutions.
• Work with cross-functional teams to evaluate design constraints, trade-offs, and project deliverables. Provide SME reviews for design verification and validation testing for electromechanical medical devices and disposables
• Ensure compliance with regulatory and quality standards (FDA, UL, REACH/RoHS, MDD/MDR).
• Manage multiple projects, track milestones, and maintain effective communication with stakeholders.
• Utilizes creative thinking and organizational skills to help solve complex problems in creative and effective ways, complete projects as assigned and achieve goals.
• Strong ability to communicate and present complex information clearly. Experience in technical writing and documentation.
• Experience in supporting multiple projects and collaborating with cross-functional teams to meet deadlines and deliver high-quality results.

SUPERVISORY RESPONSIBILITIES:

As needed/assigned.

CORE COMPETENCIES:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the core competencies required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Hands-on experience with failure analysis, root cause investigation, and structured problem-solving methodologies.
• Familiarity with design verification and validation, including protocol development, test execution, and report writing.
• Knowledge of regulated environments, including experience working under FDA, MDR,and ISO 13485 requirements.
• Understanding of manufacturing processes such as injection molding, extrusion, machining, and bonding techniques.
• Excellent organizational, analytical, and communication skills; capable of writing and presenting complex technical documents clearly.
• Strong problem-solving and critical thinking skills

• Collaborative and supportive team player.

EDUCATION and/or EXPERIENCE REQUIRED:

• BS or MS degree or equivalent in Mechanical or Biomedical Engineering, Chemistry, a related pharmaceutical science with at least 3 years of experience working with combination devices in the pharmaceutical industry.
• 3+ years of experience developing electromechanical devices in the medical device space or similar regulated industry
• Experience with mechanical testing and measurement equipment techniques.
• Familiarity with Design Verification strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, and ensuring appropriate selection of acceptance criteria and sampling plans.
• Manufacturing knowledge of injection molded, extruded, machined, formed, and/or other metal/plastic components
• Knowledge of common bonding and manufacturing processes such as solvents, UV adhesive, RF welding, etc.
• Working knowledge of statistics: design of experiments, data analysis, statistical methods and presentation of results
• Understanding of pharmaceutical and medical device development practices and regulatory compliance (FDA, UL, REACH/RoHS, MDD/MDR ).
• Strong problem-solving and critical thinking skills
• Effective communication skills, both oral and written, with strong organizational skills and attention to detail

CERTIFICATES, LICENSES, REGISTRATIONS:

• Not Required

PHYSICAL DEMANDS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Physical demands include handling materials, reagents and equipment necessary to operate and perform maintenance activities and remove waste from the laboratory.
• Domestic or international travel may be required.

WORK ENVIRONMENT:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

CORE RELATIONSHIPS:

• Relationships include interdisciplinary functions and departments including BDI Technical Operations, Quality, Regulatory Affairs, third-party contract manufacturers and laboratory service providers.

• Work with Legal re NDA, patents, etc., as appropriate.