Mechanical Engineer, Design and Development

Biotronik

  • Lake Oswego, OR
  • Permanent
  • Full-time
  • 5 hours ago
Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company's core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.Please join us as:Mechanical Engineer, Design and DevelopmentWe are looking to grow our team with the addition of a Mechanical Engineer, Design and Development Engineer to join our elite Advanced Integration Technologies group. In this role you will be responsible for developing and qualifying new processes and equipment used in the assembly of an electronic module with sustainability and profitability as a consideration. Responsibilities include specification and implementation of process control procedures, selection and introduction of new processes and equipment to improve production efficiencies and supporting manufacturing as well as company objectives. He or she will interact with internal and external customers regarding product design and development to ensure that processes and designs are compatible. This position develops manufacturing processes for new products and platforms, transitions products from development to manufacturing, creates validation plans and completes validation activities, identifies and improves manufacturing methods, and identifies and improves production yields.Additionally, this position requires dedication to increasing the knowledge and/or capability of the organization within a particular technology or function related to the processes and equipment. He or she should show a deep level of understanding of the strategic impact of certain technologies and features on the future success of the business. The individual will pioneer features and solutions that will pave the way for further advancement of our capabilities. The impact of the projects on which they work are often global.PRIMARY RESPONSIBILITIES:
  • Leads manufacturing process development.
  • Develops and performs experiments/DOEs to optimize and qualify new processes.
  • Identify and implement automation, semi-automation, and handling improvement opportunities.
  • Define requirements and specifications for processes and equipment.
  • Model and simulate manufacturing flows.
  • Specify, evaluate, select, and implement new equipment.
  • Identify and implement optimization of equipment or process performance for efficiency and capacity.
  • Integrate Manufacturing Execution System (MES) with manufacturing equipment.
  • Develop and deploy performance information systems based on MES or interface software.
  • Specify and execute installation, operation, and production qualification plans.
  • Assess, specify and deploy process control procedures.
  • Other duties may be assigned at the discretion of the manager
  • Leads technical activities for simple to complex processes often on critical processes or systems.
  • Develops new and innovative ideas that show competitive promise.
EDUCATION / EXPERIENCE REQUIREMENTS:
  • B.S. Mechanical or Materials Engineering or equivalent. Advanced degrees in the same are preferred.
  • 6-10+ years of experience in electronics manufacturing (SMT preferred).
  • Data-Driven Problem Solving - Extensive experience utilizing statistical methodologies, such as Design of Experiments (DOE), to optimize processes and resolve complex challenges.
  • Materials Science for Electronics Manufacturing - In-depth knowledge of material properties, applications, and selection criteria to enhance product quality, reliability, and cost-effectiveness.
  • Strategic Development & Business Growth -craft and execute forward-thinking strategies that drive operational efficiency and long-term success.
  • Medical Device Documentation & Compliance - Skilled in developing and managing audit-ready documentation for Class III medical implantable devices, ensuring compliance with regulatory standards and industry best practices. Expertise in validation reports, risk assessments, and data summaries.
  • Automation & Equipment Implementation - Experience in implementing, programming, and maintaining automated equipment to enhance efficiency and reliability in manufacturing and operational processes.
  • Project & Process Optimization - Strong project management expertise, including creating, overseeing, and executing detailed project plans. Adept at streamlining qualification procedures to ensure regulatory and operational compliance.
  • Technical Leadership & Collaboration - Skilled in developing and presenting proposals, driving cross-functional collaboration, and fostering alignment across all levels of an organization.
  • Process Innovation & Standardization - Experienced in defining operational requirements, refining SOPs, and developing equipment and process roadmaps to support strategic growth and continuous improvement.
PHYSICAL & TRAVEL REQUIREMENTS:The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations 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 for extended periods of time and communicate with co-workers.
  • Must be able to work a minimum of 40 hours / week.
  • Must be able to travel internationally and domestically, less than 5% of the time.
Location: Lake Oswego(0001)Working hours: Full-timeMSEI Lake Oswego Oregon (US-OR) USAJob ID: 60906Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee.Micro Systems Engineering, Inc. believes that diversity leads to strength.

Biotronik