Manufacturing Engineer, Senior
Job Summary
The Senior Manufacturing Engineer works cross-functionally to manage the production build of complex electro-mechanical medical devices in multiple product lines. The responsibilities of this position include new product introduction, pilot builds, production cell layout, production documentation, issue tracking and resolution, and continuous improvement. In addition, the incumbent coaches and mentors the broader Manufacturing Engineering team.
Key Responsibilities
Product line management: Manage production builds across multiple product lines, actively maintaining the issues list and driving necessary device improvements and changes.
Team communication: Serve as the primary point of contact to keep the production team aligned and informed on production status.
Customer interface: Work directly with customers as needed to support technical requests or specialized product needs.
New product transfer: Partner closely with development engineering to coordinate and manage the smooth transfer of new products into production.
Documentation lifecycle: Create, update, and maintain core production documentation, including materials build documentation, assembly and test procedures, part drawings, and engineering change orders (ECOs).
Continuous Improvement (CI) & Technical Awareness: Develop, implement, and lead the team’s CI efforts to ensure the department hits its established CI goals. Maintain an up-to-date awareness of medical device requirements and stay current on existing and emerging manufacturing processes and trends.
Quality Integration & Compliance: Own and execute quality documentation requirements specific to the assigned product lines. Partner directly with the Quality Engineering team to quickly address, troubleshoot, and resolve any quality issues or concerns that arise on the line.
Qualifications
Bachelor’s degree in engineering, technical, or scientific discipline
6+ years manufacturing engineering experience in an electronic-based manufacturing environment
Demonstrated experience with regulated environments such as FDA QSRs and ISO 13485 for medical devices
Proficiency with quality improvement tools and techniques
Proficiency with writing and editing production and other technical documents
Strong interpersonal communication skills
Strong analytical skills and problem-solving ability
Ability to both work independently and function as a team member and ability to lead cross-functional teams
Proficiency working with the Microsoft Office productivity suite
Preferred
Master’s degree in STEM field
Leadership experience in operations
Engineering experience with medical device manufacturing
Qualifications
Required: Bachelor’s degree in engineering, technical, or scientific discipline
Required: 6+ years manufacturing engineering experience in an electronic-based manufacturing environment
Required: Demonstrated experience with regulated environments such as FDA QSRs and ISO 13485 for medical devices
Required: Proficiency with quality improvement tools and techniques
Required: Proficiency with writing and editing production and other technical documents
Required: Strong interpersonal communication skills
Required: Strong analytical skills and problem-solving ability
Required: Ability to both work independently and function as a team member and ability to lead cross-functional teams
Required: Proficiency working with the Microsoft Office productivity suite
Compensation
The expected starting salary for this position is $100,000 to $130,000 depending on qualifications. As part of your overall rewards, we offer a comprehensive benefits program. EEO Statement Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Employment Requirement
Must be authorized to work in the United States.
Total Rewards Package
We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.