The primary purpose of this position is to design, test and technically document the feasibility, construction and production process of new and/or changed Capital Equipment medical products.
- Collaborate with a cross-functional team, including internal and external design experts and electronic equipment assemblers, to design, test, evaluate, and manufacture medical electrical equipment and systems.
- Translate customer needs and applicable standards into product requirements and design specifications.
- Perform risk analysis at the component and system levels.
- Analyze and technically document solutions to complex problems and submit invention disclosures for novel solutions.
- Work with suppliers to create or modify raw material and assembly specifications.
- Prototype devices and test fixtures to evaluate design and/or process specifications.
- Interact with machine shop personnel and external suppliers to develop tooling and equipment for test/mfgr of products.
- Consult with physicians and healthcare professionals to evaluate product design, usability, and validation test set-ups.
- Manage project time lines, resources, and budgets to ensure project success.
- Generate appropriate and robust QMS documentation to support design and risk management activities.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Ability to work in collaborative and independent work situations and environments with minimal supervision.
- Must maintain company quality and quantity standards, strictly adhere to safety requirements, and maintain regular and punctual attendance.
- Must have effective oral and written communication skills.
- Other duties as assigned.
- Minimum 4 year degree in Engineering/Technology. Masters degree in Engineering/Technology preferred.
- Minimum of 4-5 years of engineering work experience in the medical device field with a general understanding of medical device design and development. Experience with electronic hardware, software, or systems engineering for Capital Equipment development is a plus.
- Proficiency with Microsoft Office Suite software.
- Strong project management skills/experience.
- Familiarity with ISO 13485 and EN 14971.
- Experience working within a medical device Quality Management System.
- Experience with PLM and FMEA software is beneficial.
- Proficiency with PTC Creo and Minitab software is beneficial.
- Experience with IEC 60601 series of technical standards is beneficial.
- Experience with IEC 62366-1, "The application of usability engineering to medical devices," is beneficial.
- Must be able to perform the essential duties of the job, with or without reasonable accommodations.
- Good manual dexterity.
- Approximately 80% of the time is spent in a normal office environment requiring sitting and moving around the building, or in a "clean" environment Production setting requiring protective clothing and safety glasses.
- Approximately 20% of the time is spent in travel to various suppliers, conferences, trade shows, hospitals, and physicians’ offices.
Equal Opportunity Employer
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to supply sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position.