Senior Manufacturing Engineer I

New Product Introduction (NPI) and Lifecycle Management (LCM) group • Full-time

About the role

Manage a wide variety of technical tasks and projects in the development of new products and manufacturing processes. Lead within the New Product Introduction (NPI) and Lifecycle Management (LCM) group and serve as a key member of Acclarent’s medical device product development teams.

Responsibilities

• Contribute directly to the development of new processes and techniques to ensure products are high quality, low cost, and meet customers’ needs.
• Serve as a technical interface between manufacturing and materials, R&D, quality, regulatory, and marketing organizations.
• Design, develop, and refine processes, including scoping and challenge testing of outputs.
• Accurately and efficiently translate designs into documented processes and procedures.
• Participate in the creation and execution of engineering build packages.
• Design fixtures and tooling using SolidWorks and qualify equipment and fixtures.
• Plan, schedule, and complete projects in an aggressive manner.
• Manage product/process changes and design/develop new products and processes.
• Solve production process problems; familiar with plastic and metal joining processes.
• Write test protocols and reports for design verification/process validation, complete testing, and transfer to manufacturing.
• Complete all required production documentation, including Manufacturing Process Instructions (MPIs), Lot History Records (LHRs), and Bills of Material (BOMs).
• Interface with external manufacturers and suppliers; lead external manufacturers in solving production process problems.
• Direct activities of technicians, as needed.
• Understand basic electronics; perform hand soldering for electrical and mechanical connections.
• Communicate business-related issues or opportunities to the next management level.
• Follow all Company guidelines related to Health, Safety, and Environmental practices.
• Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in engineering or related discipline.
• At least 4 years of experience in an FDA-regulated industry.
• Demonstrated knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO & MDD).
• Proficient with Microsoft Word, Excel, and Project.
• Able to design process tooling on SolidWorks.
• Problem-solving skills.

Preferred Qualifications

• Bachelor’s degree in mechanical or electrical engineering.
• Experience in medical device manufacturing.
• Proven application of statistical techniques and Design of Experiment (DOE).
• Hands-on lab experience.
• Verbal and written communication skills, project management, problem-solving, Six Sigma, and process excellence tools/methodologies.
• Presentation skills to deliver speeches and/or presentations effectively to a variety of audiences.
• Proficiency with SolidWorks, Excel, Minitab, Adobe Illustrator.
• Six Sigma and process excellence tools/methodologies.
• Strong written and verbal communication skills with individuals and groups at all levels.

Pay

Salary range: $81,650.00 – $112,700.00 USD. Individual pay is determined by job-related skills, experience, and relevant education or training.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Savings plan (401(k)).
• Additional benefits available here, subject to terms of respective policies and date of hire.