Job description

As the Product Development Engineer, you will be tasked with developing catheter based medical devices. You will use your engineering knowledge to lead design and development efforts assuring compliance to internal and external standards for developing quality products. You will also be responsible for conducting project management and creating product specific Design History Files.

You will be based in Sarasota, FL at our development site with our Senior Product Development Manager and our RA team and part of our QA team. Domestic travel will be expected visiting and assessing vendors and potential suppliers, attending conferences or trade shows, and performing project related studies. International travel may be expected occasionally as you will be working with a global team.

As the Product Development Engineer, you will report to the Senior Manager of Product Development, and you will be responsible for engineering tasks as described below.

Tasks and Responsibilities

• Work independently to develop novel medical devices following established design control procedures.
• Act as project/program manager for various size projects.
• Delegate tasks per project plans to assigned project team members.
• Complete risk management documentation including FMEA’s and Hazard Analysis.
• Creating and managing CAD, components, sub-assemblies, and full assemblies.
• Create functional concepts and prototypes of catheter based medical devices hands-on.
• Draft and execute test protocols and reports for all stages of product development including verification and validations (manufacturing, test method, etc.).
• Create technical specifications for new products or process improvements.
• Locating, evaluating, and introducing new materials, processes, and suppliers.
• Participate in CAPA, NC, and MRB team meetings completing relevant assigned tasks in a timely manner.
• Actively track projects to project plans and proactively report project status to project team members and management.
• Responsible for compliance to established and published guidance documents, standards, and regulations.
• Maintain Design History Files (DHF’s) per established procedures, ensuring that DHF’s are accurate, complete, and well-organized.
• Participate in product transfer to manufacturing, including assisting in manufacturing validations and process qualifications.
• Attend trade shows, conferences, symposiums, and annual meetings to obtain knowledge of industry trends.

Skillset

• Bachelor of Science in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering or equivalent Technical Degree with experience.
• 3 years of work experience preferably in the medical device industry (other regulated industries will be considered).
• Experience with Solidworks and CAD standards.
• Proficient user of Microsoft Office (365) including MS Project, Teams and Visio.
• Collaborative, self-motivated and have the ability to work independently.
• Problem solver with critical and analytical thinking.
• Excellent written and verbal English.
• Ability to travel 10-15% with the potential for international travel

What do you get?
We offer the following benefits package to full-time employees:

• 10 annual paid holidays
• 120 hours of paid time off annually
• 100% of the employee premium for health and dental insurance, option to add family
• Retirement plan with company match
• Education benefits in the form of tuition assistance

We also offer local relocation within the state of Florida.

You will be part of an organization where we value teamwork and where we look out for each other. We are of the strong belief that no one can accomplish everything or anything on their own, and therefore we value and utilize each other’s strengths. We care about and foster an environment where you can always find a helping hand across functions and borders.

Application process
Upload your resume and cover letter via the link on this site.

We will be reviewing applications on an ongoing basis and would like to get the position started as soon as possible.

We look forward to receiving your application.

About Mermaid Medical Group:
Mermaid Medical Group is a privately owned company established in 2007. With our Nordic roots and headquarters in Denmark, we value cooperation, helpfulness, and openness. We develop, manufacture, and distribute medical devices to hospitals and end users across Europe, the U.S., and Asia. We primarily work within solutions to diseases in the vascular system as well as other devices used in interventional radiology. We strive to be the preferred partner for manufacturers as well as hospitals and health care professionals so that together we can help even more patients.

Being One of Us:
We believe that as people, and as a company, We Are One. We have a culture of sticking together and doing what is best for each other and the company. We are proud of our life-saving products, and we trust that each and every one of our colleagues do their best to ensure happiness and quality of life, both for the patients who benefit from our products as well as for each other.

Job Type: Full-time

Benefits:

• 401(k) matching
• Health insurance
• Paid time off
• Tuition reimbursement

Schedule:

• Monday to Friday

Ability to commute/relocate:

• University Park, FL 34201: Reliably commute or willing to relocate with an employer-provided relocation package (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• Relevant: 3 years (Preferred)
• Medical Device industry: 3 years (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: One location

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