About Elevaris Medical Devices
Tired of working at a "good" job?
At Elevaris, our goal is not to be good, it's to be extraordinary.
Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.
Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.
About the role
An early-career engineering position responsible for supporting product design, development, and sustaining engineering activities within a regulated medical device environment. The role performs assigned technical tasks under the direction of senior engineering staff and contributes to design control, documentation, and cross-functional product support activities.
This position has limited independent decision-making authority and is expected to develop technical proficiency and regulatory knowledge under supervision.
What you'll do
ESSENTIAL FUNCTIONS/MAJOR RESPONSIBILITIES:
- Execute assigned tasks in support of new product development activities, including prototyping, testing, verification, and validation
- Act as the engineering partner for the Commercial team in sales opportunities and manufacturing team by providing technical support, coordinating product development activities and bringing the opportunities to manufacturing realization.
- Prepare and maintain design control documentation in compliance with FDA regulations, cGMP requirements, and ISO 13485 standards
- Support design transfer activities to manufacturing, ensuring documentation and specifications are complete and accurate
- Assist in sustaining engineering activities, including implementation of design changes, documentation updates, supplier changes, remediation activities, and product extensions
- Create and revise engineering drawings, 3D models, and specifications using SolidWorks or other approved CAD systems
- Support investigations related to product non-conformances and assist with corrective and preventive action activities (CAPA)
- Provide technical support to Manufacturing, Quality, Regulatory, and Supply Chain functions as assigned
- Assist in supplier qualification activities and specification development
- Works under direct supervision of senior engineers or engineering management
- Follows established engineering procedures and quality system requirements
- Escalates technical issues and decision points appropriately
- Limited authority to approve documentation as defined by company procedures
- Maintain accurate engineering records in accordance with document control requirements
- Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
- Other duties as assigned by management
MINIMUM REQUIREMENTS:
- Bachelor’s degree in engineering (Mechanical, Biomedical, Manufacturing, or related discipline), or equivalent, relevant experience
- 0–3 years of relevant engineering experience (internship or co-op experience acceptable)
- Working knowledge of fundamental engineering principles
- Basic understanding of FDA, cGMP, and ISO 13485 regulatory requirements
- Proficiency in Microsoft Office Suite
- Experience with SolidWorks or similar CAD software is required
- Effective written and verbal communication skills
PREFERRED SKILLSET:
- Exposure to medical device product development
- Experience supporting verification and validation testing
- Familiarity with structured problem-solving methodologies
- Experience in a regulated manufacturing environment
PHYSICAL DEMANDS & ADA STATEMENT:
The physical demands described within the Essential Functions section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers, co-workers and external partners. Contact your manager or HR to understand the Work Conditions and Physical requirements that may be specific to your role.
An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.
The pay range for this role is:80,000 - 92,000 USD per year(Wilmington MA)
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