US_Process Engineer IV

Job Title: US_Process Engineer IV
Job Location: New Richmond,WI (Hybrid)
Job Duration: 18 Months on W2

DESCRIPTION
Location: Hybrid remote candidates that have a commutable distance to New Richmond, WI (40 miles east of Minneapolis/St. Paul metro area and 65 miles west of Eau Claire, WI). Expectation 75% onsite at CMO.

EXECUTIVE SUMMARY
The Senior Process Engineer will be responsible for providing drug delivery device production innovation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at ***.
The candidate has in depth experience in high volume manufacturing processes and methodologies and leads process development to support clinical and commercial production activities within ***'s device development programs. This includes engaging internal partners and external design/development/manufacturing partners and component suppliers.

The Senior Process Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance to and coordinate work activities of other personnel. The work is reviewed with a focus on long-term perspectives, as the candidate establishes his/her own work priorities and timelines.

JOB RESPONSIBILITIES
The incumbent in this position will be responsible for providing design, development, and commercialization support to project teams that are developing combination drug delivery devices for parenteral pharmaceutical therapeutics at ***. The candidate will work independently without appreciable direction from project teams or functional management. The work is reviewed upon completion. This objective will be accomplished by executing activities in the areas of:

PROCESS ENGINEERING
Provide DFM/DFA assessment of container-device, and development of testing methods to assess container and deliver system quality and functionality for existing and new technologies.
Use of state-of-the-art technology to lead process development to enable clinical and commercial production in our worldwide network.
Extensive application of tools to assess design process capabilities such as tolerance analysis, design of experiments, design for reliability, quality by design, design for six sigma, failure modes effect analysis
Characterize and evaluate critical process parameters (CPPs) using appropriate tools such as DOEs, components of variance, house of quality, etc., leveraging electromechanical presses and custom fixtures to run simulations in the lab.
Characterize material attributes (MAs) using appropriate tools such as tolerance analyses, empirical / mechanistic modeling with Monte Carlo simulation, etc.
Support or lead evaluations and investigations applying the most appropriate root cause analysis tools and methodologies.
Procure lab-scale clinical manufacturing equipment. Design, fabricate, and procure fixtures for device assembly and testing.
Author / review documentation related to clinical and commercial equipment qualification activities including pFMEAs, FAT, IOQ, and PQ. Author / review process validation protocol(s) and report(s).
Author / review SOPs for clinical/ commercial manufacturing (including labeling, packaging, preventative maintenance, and equipment operation).
Provide engineering technical leadership to internal cross functional team and external development partners and component suppliers
Recommend assembly processes and techniques that provide the most cost effective, robust and reliable performance for medical devices

QUALITY SYSTEM COMPLIANCE
Understand, implement, and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
Developed root cause analysis on manufacturing defects and collaborated in the completion of Engineering
Change Request (ECR), Material Review Board (MRB), and Corrective and Preventive Action (CAPA)
Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
Assist with resolving issues arising from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
Ensure compliance of training to PQS and job-related requirements.

DESIGN CONTROLS
Responsible for transfer of design to commercialization
Ensure product quality and design requirements are traced through the equipment development, process development and validation process.
Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
Participate in hazards analysis and design assessments and reviews.
Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
Interfaces and Collaboration
Regularly interface with leaders in Contract Manufacturing, Procurement, Quality, Complaints and Regulatory Affairs.
Regularly interact at a detailed technical level with design engineers, equipment and production engineers.
Support supplier selection through assessment of supplier capabilities for existing equipment and custom automation development, acceptance and installation
Collaborate with internal / external teams to translate design requirements into clinical and commercial processes

QUALIFICATIONS
Education and Industry Experience
B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, or the equivalent.
At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
In depth experience in high volume manufacturing processes and methodologies, with an emphasis in plastic molding and mechanical assembly is expected.
Demonstrated success in project planning, resource management, liaison with engineering and manufacturing resources in other countries is critical.
Experience working with control systems to be used in production and batch release.
Strong expertise with statistical handling and interpretation of data, technical report writing and reviewing.
Familiarity with risk management tools; develop FMEAs of the products and ability to assess changes, non-compliances, etc., with risk assessment methods.

TECHNICAL KNOWLEDGE
Strong skills in relevant modeling and design tools, design controls and/or statistical analysis. Examples may include:
At least 5 years experience supporting process development from feasibility to New Product Introduction
Interaction with Equipment/Process: Plastic Heat stake, Plastic Laser welding, Laser Etching, our client Printers,
Leak tests (pressure decay), Flow test, Bubble test, drop test, Pull test, semi-automated and automated
Assembly equipment, Functional Testers, Smart-scopes, Height gauges, Vision Systems
Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
Device Design: CADD (Solidworks, AutoCad), Design for Manufacturability, Molding.
Full data and statistical analysis (JMP, Minitab) and Design of Experiments, and providing detailed review of data with an emphasis on statistics.
Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, User Requirement Specifications (URS), Factory/Site Acceptance Testing (FAT/SAT), test protocols, technical reports, control systems to be used in production and batch release and risk management tools (methods, FMEAs, non-compliances, etc)..
Six Sigma (Green/Black Belt): DMAIC and DFSS

INTERPERSONAL SKILLS
Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., validation, quality, and program management) and collaborative environment is very desirable.
Excellent oral and written communication skills are required.
Able to work with external design/development and production partners is also highly desirable.
Highly organized and detail oriented.
Excellent leadership skills.
Demonstrated success in project planning, resource management, and liaising with engineering and manufacturing resources in other countries.

TRAINING REQUIREMENTS
Core training is mandatory and must be completed within the allotted time frame beginning with on-board date.

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