Sr. Product Development Engineer--Hybrid

AngioDynamics; Marlborough (MA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

A leading company in medical devices is seeking a Sr. Product Development Engineer to oversee the development of innovative medical equipment. This hybrid role includes leading technical design aspects, managing external partners, and ensuring compliance with industry standards. The ideal candidate should have a strong engineering background with significant experience in product development and excellent problem-solving skills.

Benefits

Comprehensive benefit plan

Career development opportunities

Training programs

Qualifications

• 8 years of experience in medical capital equipment product development.
• Experience managing technical development partners.
• Strong knowledge of FDA, ISO, and GMP standards for medical capital equipment.

Responsibilities

• Lead design and development of new medical device products.
• Compile and analyze operational, test, and research data.
• Innovate and implement processes, procedures, and tools.

Skills

Problem Solving

Interpersonal Skills

Communication Skills

Organizational Skills

Education

Bachelor’s Level Degree in Biomedical, Electrical, or Mechanical Engineering

Tools

SolidWorks

Minitab

MS Office

Job description

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JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE

It takes a team of talented people to become one of the world’s leading providers of innovative medical devices.

AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.

We Accomplish This Through

• A Commitment to the Highest Standards of Quality
• Relentless Innovation
• Operational Excellence
  
  
  

Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry.

We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

JOB SUMMARY – To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

This position is responsible for leading the technical aspects of design and development of new medical device/equipment products from initial concept stage through to release and includes evaluating designs through modeling and testing. This position will be managing the work of 3rd party design and development partners This position acts as a senior collaborator, participating in and contributing to the development of project requirements, technical studies, investigations and designs in support of assigned projects. Manages work activities for systems (software, electrical, mechanical and disposable) portions of the capital equipment projects. This position is also responsible for managing sustaining activities and authoring and executing system V&V protocols.

Essential Duties And Responsibilities

• Develops new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects. Assist production personnel on assigned project.
• Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
• Innovate, design, develop, optimize and implement processes, procedures, tooling and equipment for new products with specific emphasis on design for manufacturability.
• Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment.
• Assist in the development of less experienced staff.
• Research applicable codes and standards.
• Estimate project requirements and project schedules
• Establish system level design concepts for Medical Capital Equipment.
• Prepare project specifications.
• Produce associated Requirement Specification and Verification and Validation documentation.
• Draft system architecture and design documentation. Document and demonstrate solution by developing documentation, flowcharts, layouts, and drawings.
• Investigate, identify and resolve technical problems and establish procedures and corrective actions to avoid recurrences.
• Perform engineering duties that require exercise of judgment and application of standard engineering principles and practices.
• Work from instructions, drawings, proposals, specifications, and other important information.
• Establish formats and instructions.
• Determine operational feasibility by evaluating analysis, problem definition, requirements, solution development, and proposed solutions.
• Improve operations by conducting systems analysis; recommending changes in policies and procedures.
• Update job knowledge by studying state-of-the-art development tools, hardware requirements, participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• May perform other duties as assigned
  
  
  

Education And Experience

• Bachelor’s Level of Degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or similar Engineering field of study
• 8 years of demonstrated experience in medical capital equipment and disposable device product development.
• Any preferred education, experience or certifications: 5+ years of medical device experience
  
  
  

Skills/Knowledge

• Prior experience with SolidWorks and Minitab software
• Prior experience managing multiple technical development partners
• Knowledge of process controls, equipment design, electrical and instrumentation drawings, and PC-based operator interfaces and software
• Intimate working knowledge with medical capital equipment FDA, ISO, and GMP standards.
• Specific experience developing medical capital equipment (RF systems, Cryo systems, microwave, etc.).
• Specific experience with integration of capital equipment into hospital EMR and security requirements.
• Strong hands-on knowledge of product development methodologies and practice.
• Excellent problem solving skills
• Strong interpersonal skills, flexible, effective team player
• Independent and detail-oriented
• Proficient in the following computer software applications: MS Office products
• Exceptional interpersonal skills.
• Strong organizational skills.
• Strong communication skills (written and verbal).
• Ability to effectively communicate both internally and externally.
• Ability to read and interpret documents such as safety rules, operating and maintenance. instructions, and procedure manuals. Ability to write routine reports and correspondence.
• This position requires some travel up to 20% of the time.
  

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected status.

The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.

Your ultimate salary may vary depending on your job-related skills, knowledge, and experience.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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