Manufacturing Engineer

Key job responsibilities:

• Lead, execute the project activities and collaborate with cross functional teams to support successful project delivery.

• PPAP execution and documentation support, BOM and EIS updates, Manufacturing Procedure updates, inventory planning coordination, readiness tracking and reporting of all project deliverables.

• Create Validation Master Plans, process validation protocols, and reports, ECN and non-ECN documents as needed to support the project.

• Engineering study protocols and reports, prepared in accordance with project timelines and priorities established

• Change control assessments, work instructions, batch records, and related forms and other documents as needed, developed with appropriate inputs and training as provided by to ensure compliance and successful execution of deliverables.

• Support the expansion of prefilled syringe filling and plunger insertion capacity through vendor sourcing, User Requirements Specifications (URS) development, capital requests, FAT/SAT execution, validation, and cross‐functional project management.

• Identification, sourcing, and evaluation of automation and semi automation solutions.

• Coordination with vendors for equipment design, procurement, and implementation.

• Preparation of capital request documentation.

• Data collection and analysis for inspection processes across subassembly and finished goods.

• Identification of redundant or non‐value‐added inspection steps

• Collaboration with SMEs, Quality, and Operations to optimize inspection strategy

• Support the manufacturing operations through process optimization, waste elimination, equipment validation, documentation updates, and cross‐functional problem solving.

• Develop, execute, and support closure of:

• Factory Acceptance Test (FAT) protocols

• Site Acceptance Test (SAT) protocols

• Equipment and process validation protocols (IQ/OQ/PQ as applicable)

• Lead and coordinate project meetings, track action items, and maintain project deliverables and timelines.

• Develop and implement change controls (e.g., within PEGA or applicable systems), including:

• Impact assessment on procedures, batch records, and forms

• Updating documentation and supporting training activities

• Support process improvement initiatives, including:

• Identification and elimination of waste and inefficiencies

• Updating process flows, layouts, and work instructions

• Validation of new or modified equipment to improve efficiency and throughput

• Support engineering studies, data analysis, and technical documentation required for process, inspection, or equipment improvements.

• Coordinate with manufacturing teams to secure line time and execute builds required for validation, testing, and process improvements.

• Creation and execution of change controls in PEGA. Support coordination of internal and external testing activities as required.

• Ensure all activities are executed in compliance with Quality System, GMP requirements, and applicable regulatory standards.

• Technical Writing skills as applied to manufacturing documentation and process improvement - Experienced in the creation and revision of technical documentation.

• Carries out all other duties and responsibilities as assigned.

• Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP).

• ISO compliance, FDA 21 CFR 820 compliance, and cGMP efforts - Understands and has knowledge of FDA and ISO regulations and cGMP.

Qualifications

Knowledge and Skills:

• Minimum of 7 years of work experience in a manufacturing environment. Preferably in the high-volume production of medical devices. Able to organize and prioritize assignments.
• Experience in Manufacturing processes knowledge such as Castings, Injection Molding, Sheet Metal, welding, Machined components - Understands some fabrication methods, Sterilization Process and their applications.
• Demonstrates excellent written and verbal communication skills across all levels.
• Ability to represent functional and operations organization with clarity
• Supports and drives change management within function
• Functional or cross functional liaison with stakeholders concerning operational or project deliverables.
• Ability to manage customer satisfaction initiatives.
• Experience in Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO); minimum 7 years working in a regulated environment.
• Experience in Lean Manufacturing initiatives with an eCLIENT in continuous improvement.
• Six Sigma certification (greenbelt or blackbelt) preferred.
• Experience in applying Manufacturing Statistical methods and statistical tools. Strong experience using Microsoft tools and SAP.
• Proven ability to work independently and meet deadlines with no supervision.

Required Education and Experience:

• Requires a bachelor's degree in mechanical engineering or related field with 7 years of experience in a manufacturing engineering role.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.