Mechanical Engineer III - Advanced Surgical

Growth is our focus at CONMED, and we know that innovation is key to growth and our success! We are dedicated to innovation across our product portfolio and believe in the power of engaged talent on our teams. If you have a growth-mindset, have innovation top-of-mind, and want to be a part of a high performing team, consider applying to join CONMED as a Mechanical Engineer III.This

position is for a critical member of our Advanced Surgical division's R&D team, based in Denver, CO. The engineer will have immediate opportunities to contribute to CONMED’s active product portfolio with a focus on minimally invasive surgical technologies designed to deliver real benefits to surgeons, hospitals, and their patients. This position will be dedicated to leading and overseeing EUMDR remediation as a mechanical engineering technical lead across Advanced Surgical’s portfolio.

This position is based in Denver, Colorado area and follows a hybrid work schedule.

Candidates residing outside of the Denver area are encouraged to apply. Relocation assistance is available for qualified candidates who are selected for the role and require relocation to the Denver metro area.

The annual salary range for this position is $82,000- $125,000

Advanced Surgical Products Include:

Advanced insufflation systems

Advanced energy systems

Advanced smoke management systems

Laparoscopic surgical instruments

Responsibilities:

Lead and support remediation design activities for medical devices in accordance with EU MDR and ISO 13485.Guarantee that all designs comply with relevant industry standards, safety regulations, and quality control procedures.

Assist with quality management system reviews and participate in external audits to ensure compliance and continuous improvement.

Possess a comprehensive understanding of the design process and demonstrates the ability to independently develop test protocols, reports, and presentations.

Conduct thorough investigations to identify root causes of product issues and implement corrective and preventative actions.

Execute conceptual and detailed designs, CAD modeling, prototyping, and troubleshooting with a comprehensive understanding of the entire product development cycle.

Conduct design analyses including theoretical calculations for component fit and tolerance analysis and stress calculations.

Conduct verification and validation testing.

Engage with customers to gain a deep understanding of their needs and meticulously define project requirements, ensuring precision and alignment with their expectations.

Develop a project schedule and budget in collaboration with the project teams to ensure alignment and successful execution.

Lead high-performance, cross-functional projects.

Communicate technical concepts and design solutions to stakeholders, including senior management and customers.

Contribute to procedural updates and best practices and create job aids to assist other engineers in completing a wide range of job functions, from common to complex tasks.

This role requires a talented and driven team player who is eager to contribute to multiple exciting projects and initiatives. If you enjoy working in a cross-functional and fast-paced team environment, we invite you to apply for consideration!

Required Qualifications:

B.S. in Mechanical, Biomedical Engineering, or highly related field required5 years related experience in product development engineering with a bachelor’s degree; 3 years with a master’s degree

Intermediate skills in 3-D CAD software such as Solid Works or equivalent

Experience working in a regulated environment, such as FDA 21 CFR 820 or similar

Strong understanding of design controls (21 CFR 820.30), ISO 13485, ISO 14971, and IEC/ISO standards related to the product type Experience…