NPI and Sustaining Systems Engineer, Senior

Senior New Product Introduction and Sustaining Systems EngineerExceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.The Senior New Product Introduction and Sustaining Systems Engineer serves as a technical leader within the R&D organization, driving innovation and lifecycle support for multiple new product introduction and commercial medical device products.

This position applies Forj Medical Standard Operating Procedures and cross-functional knowledge of electronics, software, and mechanical technologies to support integration and continued manufacturing of embedded medical devices. This role combines deep systems engineering expertise with strategic leadership to ensure product reliability, compliance, and performance throughout the product lifecycle. Assignments may be broad in nature and require creativity and ingenuity.Essential Duties and Responsibilities:Technical Leadership & ArchitectureDefine, understand and maintain system-level architecture for transfer and commercial productsFrequent customer interactionLead analysis and trade-off decisions across multiple engineering disciplinesScope and drive implementation of design change activitiesSupport customer needs for ongoing production of complex electromechanical equipmentProvide task estimates (scope/schedule/budget) in support of projects, including participation with formal statements of workNPI SupportAssess customer design files and related documentation for manufacturing readiness and technical riskLead manufacturing transfer activities, including planning, coordination, and production handoffSupport pilot builds and early productionLead the development of missing documentation as neededLifecycle Management & Commercial Product EngineeringDrive commercial engineering projects focused on product enhancements, cost optimization, and obsolescenceServe as the primary R&D technical authority for manufacturingIdentify, document, and address concerns related to proposed design changes to established product lines (e.g. flag changes that may impact product safety compliance).Compliance & QualityEnsure adherence to FDA QSR, ISO 13485, IEC 60601 standards and Forj Medical SOPsLead and support process improvement initiativesCross-Functional Collaboration & MentorshipRepresent the organization in providing solutions to technical challenges with specific projectsProvide mentorship of junior engineersQualifications:Bachelor's or Master's degree in Systems, Software, Electrical, Mechanical, or Biomedical Engineering or similar4-6 years of experience in medical device development or sustaining engineeringExperience with Class II and/or Class III productsExperience in Contract Development & Manufacturing preferredDemonstrated understanding and wide application of technical principles, theories, and concepts in the field of medical devices, general knowledge of other engineering disciplinesProficient at quickly solving medium-complexity system-level problemsIn depth knowledge of FDA QSR's, ISO 13485, and IEC 60601 for medical devicesExperience in interpreting and applying technical regulatory requirements to medical devicesExcellent interpersonal skills with multiple disciplines & clientsAbility to work independently and self-drivenEEO StatementForj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Employment RequirementMust be authorized to work in the United States.Compensation and Total Rewards PackageThe salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.