Senior Mechanical Engineer, Medical

Goddard Technologies, Inc.; Beverly (MA); On-site; USD 105,000 - 135,000; Full time

Benefits offered by this job

Flexible Time Off

401(k) retirement plan

Comprehensive health coverage

Fully paid parental leave

Company engagement activities

Job summary

A leading engineering firm in Beverly is seeking a Senior Mechanical Engineer with over 5 years of experience in medical devices and mechanical design. The role involves leading projects, facilitating client interactions, and mentoring team members. Candidates should have a bachelor's degree in mechanical engineering, proficiency in SolidWorks, and knowledge of FDA design controls. This opportunity offers a competitive salary and benefits including flexible time off and 401(k) retirement plan.

Qualifications

• Proven experience in medical devices, product development, and mechanical design.
• Familiarity with FDA design controls and standards such as ISO 13485.
• Experience in Neurology, Cardiovascular, Orthopedics, Women's Health, and Diabetes.

Responsibilities

• Manage client interactions regarding deliverables and deadlines.
• Create mechanical concepts for packaging strategies.
• Lead design history file development and formal verification testing.

Skills

DFX expertise

Teamwork and communication skills

Mechanical design

Product development

SolidWorks proficiency

Education

Bachelor’s degree in mechanical engineering or related field

Tools

SolidWorks

Job description

Our Mission

Through inspired engineering and design, we deliver outstanding solutions that positively impact lives. We use an interdisciplinary development process that combines our diverse engineering experience with creative industrial design solutions. We succeed when our partners succeed – it’s all about solving the most complex challenges by creating transformative technology.

Our Culture and People

At Goddard, our most important asset is our people. We don't just work together; we thrive together. We foster a culture of collaboration, continuous learning, and mutual support. We believe in taking exceptionally good care of each other because great teams build great solutions. If you are someone who embodies the values of accountability, inspiration, dedication, efficiency, innovation, integrity, quality, and reliability, we want you on our team. Come be a part of a workplace where your ideas are valued, your growth is encouraged, and your contributions make a real impact. Join us in shaping the future of transformative technology – together.

The Role

The Senior Mechanical Engineer will have5+ years of experience in medicaldevices, product development, mechanical design, and engineering. This role will lead, advise, and assist a team of engineers to execute projects, ensuring on-time submission of deliverables.

Responsibilities

• Manage and facilitate client interactions with clear communication as it relates to deliverables, design reviews and deadlines.
• Work independently, as a team leader or as part of a team to create mechanical concepts for overall packaging strategies, mechanisms, and parts while balancing function, appearance, form, and budgetary requirements.
• Provide DFX expertise to ensure designs are optimized.
• Design and develop precision mechanical products utilizing injection molding plastics, machining, casting, laser cutting and welding, extrusion and 3D printing.
• Execute iterative development cycles using rapid prototyping, root cause analysis, tolerance stack analysis, FEA, concept down-selection tools, or other engineering methods.
• Lead and document Design History File development activities including but not limited to Design and Development planning, system requirements, RISK management, hazard analysis, xFMEA, design inputs and outputs, test plans, protocols and reports.
• Plan and execute formal verification testing, including test method development, test method validation, data analysis, and design of experiments.
• Work with team members to resolve conflicts among resources and between clients and engineering teams.
• Coordinate priorities and design decisions between interdisciplinary team members including electrical engineers, software engineers, human factors engineers, systems engineers and industrial designers.
• Operate within a Quality Management System as well as contribute to continuous improvement efforts.
• Remain apprised of the progress of certain projects, paying particular attention to any developing problems, and participate in major problem resolutions.
• Support project scoping activities to support Business Development and Sales teams.
• Communicate to senior management any significant project risks or deviations from the plans.
• Serve as a mentor for less experienced team members.
• Travel as needed (valid driver’s license and vehicle required).
• Keep all privileged information private and confidential.

Qualifications

• Bachelor’s degree in mechanical engineering or related field.
• Proven experience in one or more of the following industry segments: Neurology, Cardiovascular, Orthopedics, Women's Health, and Diabetes.
• A functional knowledge of FDA design controls 21 CFR Part 820 and recognized standards such as ISO 13485 and 14971 and IEC 60601.
• Proficiency in the latest version of SolidWorks CAD package.
• Working knowledge of common sterilization methodologies, biocompatibility, sterile packaging, shelf-life, and simulated distribution validation testing.
• 2D drawing creation, GD&T, tolerance analysis
• Strong teamwork, interpersonal and communication skills, and a demonstrated ability to work at a high level of performance both independently and collaboratively.

Our Benefits

Flexible Time Off: Benefit from our generous flexible time off policy. We also provide sick leave and bereavement time because we understand that not all time off is for fun.

Retirement Savings: Invest in your future with a 401(k)-retirement plan. Goddard contributes 3% of your annual salary directly into your 401(k) account—regardless of your own contributions.

Health Coverage: Access to comprehensive medical, dental, and vision insurance for you and your family. Goddard contributes 80% of monthly premiums for all medical plan options.

Family Support: To take the time you need to welcome the newest member of your family, Goddard offer 6 weeks fully paid parental leave with support of PFML state programs.

Company Engagement: Engage with your colleagues through a variety of regular company and team events, including weekly social hours, Athletic Club outings, and department outings.

Pay Range

105,000 - 135,000 USD per year (Beverly Office)