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Senior Design Engineer
Job in
Indiana Borough, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-03-07
Listing for:
MicroAire Surgical Instruments, LLC.
Full Time
position Listed on 2026-03-07
Job specializations:
-
Engineering
Mechanical Engineer, Product Engineer
Job Description & How to Apply Below
This Senior Designer (Microaire Senior) is responsible for executing and leading product design improvements, cost reduction initiatives, and resolving technical challenges in existing products. This role supports both Sustaining Engineering and Innovation teams, contributing to new product development through design, testing, and validation activities. The engineer will develop detailed models, specifications, and documentation while collaborating closely with cross-functional leaders to deliver robust, high-quality engineering solutions.
** Mandatory
Skills:
*** 3+ years of experience in creating and executing Change Orders, including design updates, 3D models, drawings, and supporting documentation such as change justifications, tolerance analyses, and verification testing.
* Proficiency in 2D drafting and 3D modelling, preferably using Solid Works and Strong knowledge of ANSI Y14.5 geometric dimensioning and tolerancing standards.
* Experience in Implement design control updates for product improvements or post-market activities (e.g., field failures, customer complaints, or research findings).
* Strong communication and interpersonal skills with the ability to manage multiple priorities and deliver within project timelines.
** Desired
Skills:
*** Prepare and submit Change Requests and support approval workflows.
* Create and execute Change Orders, including design updates, 3D models, drawings, and supporting documentation such as change justifications, tolerance analyses, and verification testing.
* Implement design control updates for product improvements or post-market activities (e.g., field failures, customer complaints, or research findings).
* Contribute to updates of Product Trace Matrices, Risk Analyses, and Usability Engineering documentation.
* Support regulatory documentation by providing inputs for Technical File updates, FDA submissions, or registration support for global markets.
* Collaborate with Product Innovation and Product Strategy teams to assist in user evaluations, usability testing, and design validation for both sustaining changes and new product development.
* Support Design Verification activities, including developing test methods, performing analyses, and reviewing results to confirm compliance with design inputs.
* Work closely with Manufacturing Engineering to ensure effective design transfer, including review of manufacturing instructions and inspection criteria.
* Coordinate with external resources such as suppliers, prototype vendors, and material providers to support design execution.
* Collaborate cross-functionally with Project Management, Quality, Regulatory, and Testing teams to deliver design tasks on schedule and per standards.
* Proficiency in 2D drafting and 3D modelling, preferably using Solid Works.
* Strong knowledge of ANSI Y14.5 geometric dimensioning and tolerancing standards.
* Solid understanding of mechanical component and assembly design, including material selection, part tolerancing, tolerance stack-up analysis, and mechanical stress analysis.
* Familiarity with metallic and polymer materials commonly used in precision or medical applications (stainless steel, aluminium, engineered plastics).
* Working knowledge of manufacturing processes such as machining, injection moulding, additive manufacturing, and finishing techniques.
* Awareness of factors influencing durability and reusability of mechanical or surgical instruments (corrosion, wear, sterilization, and thermal cycling).
* Basic understanding of design verification and validation methodologies, test development, and data analysis
* Exposure to design control processes under ISO 13485, ISO 14971 (Risk Management), and CFR Title 21 Part 820.30.
* Awareness of IEC 62366 (Usability…
Position Requirements
10+ Years
work experience
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