Development Engineer

Corin Group; Raynham (MA); Vor Ort; USD 80.000 - 100.000; Vollzeit

Zusammenfassung

Corin Group seeks a Development Engineer to advance New Product Introduction of hip and knee implants and robotic technologies within the Corin Ecosystem. You will develop hardware and instrumentation and support existing products through design optimization.

You will create design documentation, perform CAD validation, manage projects to budget, lead cross‑functional teams, update DHF and risk files, ensure CAPA and QMS compliance, and produce test protocols.

Qualifikationen

• Advanced Apprenticeship or university degree in Mechanical Engineering, Biomedical Engineering, or Product Design.
• Experience with regulated medical devices preferred.
• Knowledge of CAPA, QMS (ISO13485) and GMP practices.
• Experience with CAD validation and manufacturing documentation.

Aufgaben

• Create design documentation to current SOPs and procedures.
• Perform structural calculations, tolerance analysis, and CAD assembly review.
• Validate and verify designs to support development.
• Create and maintain design/manufacturing docs for robotics and hardware.
• Develop 3D and 2D CAD drawings for design and manufacturing use.
• Lead design projects within budgets and plans.
• Lead cross-functional project teams (QA, RA, Clinical, R&D, Manufacturing).
• Update Design History File (DHF) and risk management documentation.
• Provide design and process support to Corin departments, sub-contractors, and customers.
• Produce test protocols and reports for performance testing of instruments and implant devices.
• Adhere to QMS requirements in line with ISO13485 and GMP FDA21 CFR Part 820.
• Support CAPA as per SOPs and Global Objectives.

Kenntnisse

CAPA process

Manufacturing processes

Inspection methodology

Regulated industry experience

Problem-solving techniques

Ausbildung

Mechanical Engineering degree

Biomedical Engineering degree

Product Design degree

Tools

Siemens NX

SolidWorks

Jobbeschreibung

The key purpose of the Development Engineer role is developing NPI (New Product Introduction) medical technology devices, hardware and instrumentation for the hip and knee implants. The focus is on the development of robotic technologies integrated with the Corin Ecosystem. Additionally, the engineer will support already commercialized products by Corin Group through design optimization and maintenance.

The key responsibilities of the Development Engineer

• Create the necessary design documentation to current SOP’s and design procedures.
• Make structural calculations, perform tolerance stack analysis and assess CAD assembly.
• Validate and verify to support the development process.
• Create and maintain design and manufacturing documentation for robotic technologies, instrumentation and hardware
• Create and maintain 3D and 2D CAD drawings and models for design and manufacturing use.
• Manage specific design projects as and when required, to budgets and plans.
• Lead and participate in project core teams, liaising with QA, RA, Clinical, R&D, Manufacturing, and Production Engineering as part of CAPA, continuous improvement, and optimization projects.
• Critical review and updating of Design History File (DHF) and risk management documentation.
• Provide design and process support to Corin departments, sub-contractors, and customers.
• Produce test protocols and reports to support performance testing of Corin instruments and implant devices.
• Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820
• Ensure that process & timeline requirements for Corrective & Preventive Actions (CAPA) are met following Corin’s Standard Operating Procedures (SOPs) and support of Corin’s Global Objectives for CAPA

The ideal Development Engineer will have/be

• An advanced Apprenticeship or University degree in relevant subjects such as Mechanical Engineering, Biomedical Engineering, Product Design, or equivalent experience.
• A competent CAD operator, with experience with Siemens NX and/or SolidWorks would be an advantage.
• Previous work experience in a regulated industry, preferably medical devices.
• Knowledge of manufacturing processes and inspection methodology.
• Knowledge of the CAPA process and associated problem-solving techniques.

The pay range for this position is $80,000 - $100,000. The specific pay offered may be influenced by a variety of factors, including the candidate’s experience, education, and skill set.

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.