Design Engineer

OP Specialty Bracing; Stoughton (MA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Vision Insurance

Long & Short-Term Disability

Life Insurance and AD&D

Retirement Savings Plan

PTO & Holidays

Job summary

OP Specialty Bracing in Stoughton, MA is seeking a Design Engineer to research, design, and develop medical implants and instruments using CAD to generate 3D models. Models become specifications and prints.

You will work with manufacturing, quality, purchasing and marketing to ensure feasibility, cost effectiveness and regulatory compliance, using ISO 13485 standards and GD&T. Strong CAD skills and five+ years of experience are preferred.

Qualifications

• 2-year technical degree required; BS strongly preferred.
• 5+ years related engineering/design experience.
• Broad machine design experience; metal and plastic fabrication.
• Proven skills with defined CAD packages; ISO 13485 design controls.
• Good verbal and written communication; medical device development experience preferred.

Responsibilities

• Design, develop and test medical devices using CAD and 3D models.
• Build prototypes and evaluate designs; iterate until working.
• Collaborate with manufacturing, quality, purchasing and marketing.
• Apply ISO 13485, GD&T, and ASME standards to engineering prints.
• Maintain documentation in Master Control and related records.

Skills

CAD proficiency

English communication

Problem solving

Time management

Independent work

Team collaboration

Documentation

Education

2-year technical degree

Bachelor's degree preferred

Tools

CAD packages

Job description

OP Specialty Bracing is growing, and we believe our team is the key to our success. We are hiring a Design Engineer to join our team. If you are a motivated, caring individual who wants to make a difference in the lives of children, we encourage you to apply today!

Position Summary:

The Design Engineeris responsible for researching, designing and developing medical products (implants and instruments) within the assigned business unit, using CAD to generate electronic 3D Models. Those models will be verified to work as intended and subsequently turn into a specification print.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Using computer software and complex 3D mathematical models to design, develop and test new material, devices and equipment. This can involve building and evaluating prototypes; troubleshooting problems; and rethinking the design until it works correctly.
• Utilizing parametric techniques, sketcher, spreadsheets, freeform, and assembly tools within the 3D software supported by OPSB.
• Liaising with technicians and manufacturers to ensure the feasibility of a product in terms of design and economic viability.
• Discussing and solving problems with manufacturing, quality, purchasing and marketing departments.
• Creating and completing Functional Relationship Analysis (FRA) and the associated Protocols, Reports, and Layouts in the defined conditions.
• Applying current ISO 13485, GD&T, and ASME standards to engineering prints.
• Work in a strong team environment.
• Use of Master Control as a database to store and link required documentation.
• Performs all other duties as assigned by manager.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be provided to enable individuals with disabilities to perform the essential functions).

• Ability to adjust priorities and manage time wisely in a fast-paced environment.
• Maintain documents and records pertaining to research and development.
• Communicate and work well with customers.
• Read, listen and communicate effectively in English, both verbally and written.
• Be results oriented, requiring knowledge and experience in a wide variety of disciplines.
• Ability to travel as needed.
• Work independently with minimal direction.
• Demonstrate problem solving skills with high proficiency.

EDUCATION AND/OR EXPERIENCE:

• Requires a 2-year technical degree; BS strongly preferred.
• Five (5)+ years related engineering/design experience.
• Broad machine design experience. Broad exposure to metal and plastic fabrication technologies.
• Proven skills with defined CAD packages. Ability to use ISO 13485 design controls and regulations related to projects, which result in meeting global regulatory guidelines and policies.
• Good verbal and written (MS Word) communication skills. Medical device development experience preferred.

The above statements reflect the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.

Benefits Offered for Eligible Employees:

• Medical Insurance
• Vision Insurance
• Long & Short-Term Disability
• Life Insurance and AD&D
• Retirement Savings Plan
• Paid Time Off (PTO) & Holidays

Equal Opportunity Employer:

OPSB is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

#HP

At OP Specialty Bracing, kids are at the heart of everything we do. Our cause is simple: to improve the lives of children with orthopedic conditions and support their families every step of the way. From fractures and clubfoot to cerebral palsy, scoliosis, plagiocephaly, limb loss, and more, our certified clinical team treats the whole child in partnership with their care team. Helping kids is what we do; changing their lives is how we make a difference.

OPSB offers specialized pediatric clinics across the country, including in major children’s hospitals, ensuring that every child gets top-notch, kid-focused care. Our pediatric focus means that all our resources, from products to educational videos and print materials, are designed specifically towards the treatment of kids. With a growing library of resources and patient stories, we make the transition to treatment easier for families.

We’re not just providing care—we’re pioneering it! Our team is constantly developing new, cutting-edge solutions in pediatric orthotics and prosthetics, because we believe every child deserves the very best. At OP Specialty Bracing, pediatric care is not just something we do—it’s our passion, our purpose, and our promise to the kids we serve.

The pay range for this role is:

80,000 - 110,000 USD per year (Stoughton )