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Weiss-Aug · 4 months ago

Sr. Product Release Engineer

Weiss-Aug MedPharma – Fairfield, NJ

Full-time

Onsite

Senior Level, Lead/Staff

$30/hr - $35/hr

10+ years exp

Weiss-Aug is a leading provider of advanced manufacturing and engineering solutions, specializing in high-volume metal stamping and thermoplastic molding. They are seeking a Sr. Product Release Engineer responsible for designing, developing, testing, and evaluating products, ensuring that design specifications are met while overseeing the entire program lifecycle from concept to manufacturing.

Health CareMedical

Responsibilities

Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements

Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs

Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes

Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities

Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities

Understand and meet Regulatory (FDA) requirements and processes for development

Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s

Oversee the creation of BOMs and initiation of the change control process (ECO) relating to Engineering documentation

Jointly responsible for successful transfer of tooling to Manufacturing along with Tooling and Design Engineering functions

Oversee the selection and management of key suppliers and the completion of requisitions for purchased tooling or other product or services. Interface with outside suppliers to ensure they provide product or services on-time and to specifications

Assist in determining needs for additional personnel and/or training in order to meet program needs

Identify and facilitate addition of personnel, training, and special equipment needs to support project success

Interface with customer on technical and schedule-related issues, ensure program progress is communicated to customer at regular intervals

Participate in customer, internal, regulatory, and quality system audits

Support Sales as needed to assist in identifying potential leads and opportunities

Qualification

Mechanical EngineeringBiomedical EngineeringMedical Device ExperienceRegulatory (FDA) KnowledgeProduct Development EngineeringAdvanced Product Quality PlanningCross-functional Team LeadershipProject ManagementTechnical Communication