Engineering Consultant I

Position summary

Support engineering, compliance and Quality related projects. Perform and execute the tasks determined for the resolutions of the different projects, ability to perform appropriately with or without supervision, may seek guidance in resolving problems. Demonstrate ability to be self-taught, provide creative and efficient solutions to engineering challenges for tasks assigned, follows standard practices and procedures. Participates in the completion of department projects and goals, is attentive on identifying customer needs and focus on providing solutions by being recursive, analytical and results oriented. Provides effective client satisfaction and demonstrates abilities to adapt to the culture, policies and environment when performing at a client s site. Uses discretion, diplomacy and tact in interactions, is flexible, respectful and maintains the confidentiality all the time. Every action must be performed with professionalism and in compliance of regulations and standards for medical devices industry.

Essential functions:

Contributes and assists to projects team(s) according to the engineering consulting necessity of the client on the following activities: product design and development, test of materials, development of specifications, process capability studies, research investigations, report preparation, process/test documentation, CAPA, NCR, Complaints handling/Analysis, Risk Management, etc.

Ability to learn, understand, and apply specific knowledge in order to develop, review, and approve design, quality, and manufacturing documentation such as design input, design verification, design validation, process validation, quality plans, risk management, CAPA, NCR, Complaints analysis, standard operating procedures, inspection procedures, etc.

Support projects requiring Process Qualifications, Test Method Validations, Process Capability studies, Design of Experiment (DOE), FMEAs (Design and Process), and production master control plans.

Support projects requiring design history file documentation, such as Design and Development Plan, Design Input, Design Output, Design Verification, Design Validation, Design Reviews, Design Transfer, Design Changes, etc.

Support projects requiring Risk Management file and usability file documentation, such as Task Analysis, Fault tree Analysis, Hazard Analysis, use flow, DFMEA, UFMEA, PFMEA, etc.

Support CAPAs/NCRs/Complaint evaluation projects as assigned.

Support projects related to the Design of Experiments to optimize processes.

Support implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance criteria.

Perform statistical analysis using Minitab.

Develop Engineering Drawings following GD&T.

Support projects requiring process capability analysis prioritize process improvement opportunities, and innovate and implement process improvements on platform or derivative projects.

Applies technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automation.

Ensures proper documentation is completed to meet US FDA 21 CFR 820, EUMDR, ISO 13485, and other applicable international regulations and standards.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Build Quality into all aspects of your work by maintaining compliance with all regulatory requirements

Assists in special projects as assigned.

Requirements:

Advanced computer skills including Office 365 applications (Word / Excel / Powerpoint/project / Visio, Teams, etc.), and Minitab statistical analysis software is required.

SolidWorks experience preferred.

Experience with electronic data management systems is plus.

Bachelor’s Degree in Engineering or equivalent work experience.

Minimum of 2-3 years of experience in the medical device industry.

Some experience with durable medical capital equipment in addition to single-use devices is preferred. Molding and extrusion process, Assembly and Fabrication methods, polymer and elastomer properties.

Strong engineering, design, and analysis skills.

Experience with medical devices from concept to commercialization.

Demonstrated use of quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, and process validation (IQ, OQ/PQ). Must have a good understanding of 21CFR820 regulation, ISO 13485, 14971, and other harmonized standards.

We are looking for candidates located in Massachusetts area