Senior Mechanical Engineer, Medical

Goddard Technologies, Inc.; Wilmington (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

Paid parental leave

Regular company events

Job summary

A leading technology company in Wilmington seeks a Senior Mechanical Engineer with over 5 years' experience in medical device design and development. This position will lead engineering teams on projects involving mechanical design, compliance with FDA standards, and innovative product solutions. Candidates should possess a Bachelor's degree in Mechanical Engineering and expertise in SolidWorks. The role offers competitive compensation and inclusive benefits like flexible time off, comprehensive health coverage, and retirement savings contributions.

Qualifications

• Proven experience in Neurology, Cardiovascular, Orthopedics, Women’s Health, or Diabetes sectors.
• Functional knowledge of ISO 13485, ISO 14971, and IEC 60601 standards.
• Working knowledge of sterilization methodologies and biocompatibility.

Responsibilities

• Manage client interactions and deliverables.
• Create mechanical concepts for packaging strategies and designs.
• Lead design history file development activities.
• Plan and execute formal verification testing.

Skills

FDA design controls knowledge

SolidWorks CAD expertise

2D drawing creation

Interpersonal skills

Teamwork

Education

Bachelor’s degree in mechanical engineering

Job description

Role Overview

The Senior Mechanical Engineer will have 5+ years of experience in medical devices, 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, ISO 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.

Benefits

1. 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.
2. 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.
3. 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.
4. Family Support – To take the time you need to welcome the newest member of your family, Goddard offers 6 weeks fully paid parental leave with support of PFML state programs.
5. 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.

The pay range for this role is: 105,000 - 135,000 USD per year (Wilmington Office)