Product Engineer, Level II at Spectra Medical Devices, LLC – Wilmington, Massachusetts

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 experienced engineering role responsible for independently executing and leading product design, development, and sustaining engineering activities within a regulated medical device environment. This position owns defined workstreams or projects, applies engineering judgment to solve technical problems, and ensures compliance with design control and regulatory requirements.

The role operates with minimal supervision and contributes to cross-functional decision-making and product lifecycle management.

What you'll do

ESSENTIAL FUNCTIONS/MAJOR RESPONSIBILITIES:

• Lead and execute assigned tasks in support of new product development activities, including prototyping, testing, verification, and validation
• Act as the engineering partner for the Commercial and Manufacturing teams in sales opportunities, 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
• Lead design transfer activities to manufacturing, ensuring product readiness, documentation completeness and successful product implementation
• Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions
• Support investigations related to product non-conformances and assist with corrective and preventive action activities (CAPA)
• Responsible for creation of engineering drawings for product, tooling utilizing SolidWorks (3D) or CAD formats
• Serve as primary engineering interface for manufacturing, quality, regulatory, supply chain and commercial teams on assigned projects
• Support or lead supplier qualification activities and contribute to specification development and evaluation.
• Provide support to QA in product non-conformances, investigations, supplier corrective actions, and corrective/preventive actions
• 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 or equivalent, relevant experience
• 3+ years in a similar role, preferably in medical device product development
• Understanding of FDA and cGMP regulations and ISO 13485 requirements
• Technical writing skills

PREFERRED SKILLSET:

• Excellent organizational, verbal, written communication and problem-solving skills
• Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
• Ability to multi-task with strong attention to detail
• Proficient in MS Office Suite; SolidWorks and CAD systems
• Experience working in a start-up environment, helpful

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.