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Minnetronix Medical · 7 hours ago

Senior Process Development Engineer

St Paul, MN

Full-time

Onsite

Senior Level

6+ years exp

Forj Medical is dedicated to bringing life-enhancing medical technologies to market by collaborating with over 100 medical device companies. The Senior Process Development Engineer will lead the development and evaluation of new manufacturing processes, providing technical expertise and managing resources for projects.

Health CareManufacturingMedical DeviceProduct Design

Responsibilities

Proposes new process/equipment/core technology improvement concepts

Understands how user and patient needs translate to process and functional product outputs

Aids in selection of process improvements to increase UPH, yield, and manufacturability on pre-production and/or production products

Participates in strategic planning and department goal setting

Leads phase II and process related quoting activities to support new project costing

Provides guidance on process standards, templates, and best practices

Translates customer requirements into process specific outputs

Plans and manages the development and evaluation of process assembly steps

Plans, manages, and conducts activities surrounding risk assessment (e.g., FMEA) of product concepts

Participates in risk assessment (e.g., DFMEA) or product concepts and translates customer DFMEA requirements to pFMEA and team

Manages process capability, DOE, and other characterization studies to analyze and report on results using statistical analysis

Completes engineering documentation (e.g., manufacturing and inspection procedures (MIPs), router/BOM updates, etc.). to prepare and finalize documentation before verification and validation testing

Participates in project planning, business case evaluation, and project tracking

Leads customer meetings related to process specifics and process details

Manages determination of qualification requirements and criteria for new products/processes based on Intricon and customer procedures/requirements

Leads timeline planning and operations resource requests for execution of qualification activities

Prepares and releases verification/validation protocols and reports (IQ, OQ, PQ, etc.)

Leads and manages the development of master validation plan (MVP) documentation

Collaborates with other functions to execute project deliverables

Develops standard documentation methodologies

Communicates directly with customer to define validation strategy, approach, and constraints

Establishes extensive interdepartmental and interdivisional networks

Has an in-depth understanding of the various organizational interfaces (laboratory, engineering, sales, and marketing)

Implements comprehensive educational plans to develop, maintain, and expand state-of-the-art knowledge in functional area

Participates in recruiting and staffing

Qualification

Process DevelopmentDesign ControlsQuality System RegulationsStatistical AnalysisRisk AssessmentAnalytical SkillsCoaching/MentoringTechnical WritingCommunication SkillsProject Management