POSITION REQUIREMENTS SUMMARY:
This person must have commercial industry experience in a fast paced swiftly changing environment. The ME must be capable of adapting to an industry that rapidly changes due to technological advances in computing, electronics, pneumatics, and mechanics.
- Develop PFMEA’s and control plans for new and existing products.
- Ability to launch new products into production with requisite tooling and processes.
- Knowledge of lean concepts for deployment into production.
- Work within a team to ensure timely delivery of assigned action items.
- Perform troubleshooting and problem solving by employing established quality tools (5 Whys, brainstorming, etc.).
- Perform RCCA on supplied and internal products through the use of an MRB system.
- Lead continuous improvement projects on current production lines to increase productivity, decrease cycle times, etc.
- Provide feedback on engineering changes such as work instruction modifications, tooling updates, and part manufacturability for production incorporation.
- Perform floor support to help with production issues and ways to resolve these issues.
- Write production floor personnel work instructions on how to build the internal products.
- Design and update the production floor layout using CAD software.
- Provide RCCA on Out of Box Failures and how to prevent reoccurrence of the failure.
- Provide support for ECR implementation for the production team.
- Ensure manufacturability, write process, and write work instructions for production releases.
- Bachelor’s Degree in Engineering
- Minimum 2+ years of medical device or manufacturing industry experience.
- Minimum 5+ years in Manufacturing Engineering.
- Some experience with tool design and process design.
- Progression of increasing responsibility highly desired.
- Must be an organized and detail- oriented individual with the proven ability to organize projects.
- Excellent oral and written communication, presentation and interpersonal skills.
- Computer literacy is essential. Must be proficient in Microsoft Office.
- Some experience with computer (Mac and PC) configuration is essential.
- Clinical or Medical Education experience
- MRP proficiency.
- Complies with and enforces all applicable safety rules, regulations and procedures both at the Company and wherever representing the Company (i.e., program site, trade show, etc.).
- Perform all duties in compliance with legal and ethical standards.
- Maintain security of all proprietary information.
- Perform other duties as assigned or as necessity dictates.
- Ability to lift or push weight of 50 pounds (simulators)
We are an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.
FLSA STATUS: Full Time, Regular, Exempt
"Black, Indigenous, People of Color, Women, LGBTQ2, Veterans, Disabled Candidates are highly encouraged to apply."
Questions from the employer
- Are you a US Citizen or Green Card Holder? Are you authorized to work in the United States that does not now or in the future require sponsorship?
- What is your highest educational attainment? Should be at least a bachelor's degree in Engineering.
- How many years of experience do you have as a Manufacturing Engineer? (should be at least 5 years)
- How many years of experience do you have in medical device or manufacturing industry? (should be at least 2 years)
- Are you based in Sarasota, Florida? If no are you willing to relocate?
- What is your expected base salary and total compensation?