Associate Principal Engineer

This key position within the manufacturing engineering group will research dental and medical industry trends and technologies to challenge current processes and drive continuous improvement. The Associate Principal Engineer will use past experience and new learnings to deliver mid-level projects with no supervision. This role will be responsible for developing key relationships with other functions at the site and external manufacturing partners. The Associate Principal Engineer will effectively manage projects and coach/mentor junior engineers.

Job Description

KEY RESPONSIBILITIES:

General

• Lead multidisciplinary technical teams and provides key engineering functions across multiple functional groups within the site
• Present finished projects to site leadership
• Manage mid-scale projects
• Develop expertise in some areas of the dental and medical device industries
• Work with external companies/organizations on technology development while maintaining project timelines and ensuring efficient use of resources.
• Take an active role in site-level decisions and initiatives
• Provide coaching/mentorship to other engineers

Process

• Process ownership for production and assembly operations. Full scale leadership on production and assembly projects across the site.
• Recommend and implement process improvements for manufacturing procedures based on key performance indicators (KPIs).
• Lead reviews of process design for compliance with engineering principles, company standards, customer contract requirements, and related specifications.
• Look to develop alternative processes/materials/equipment to improve cost and efficiency but preserve the same output.
• Research future technologies to develop test methods that are accurate, time-efficient, and cost-effective.
• Review and assess the production "package" including work instructions, travelers, drawings, labeling, etc.
• Design and executenew process qualifications for new base technologies across multiple manufacturing platforms.
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements
• Attend technical conferences and trade shows to look for new opportunities in the areas of process equipment, packaging, product treatment, metrology, materials and plan productivity
• Lead initiatives for the development, introduction, improvement and sustainment of manufacturing processes. This includes introduction of Lean manufacturing techniques and a philosophy of continuous improvement.

Design/Development

• Use current engineering best practices in the design, development, testing, documentation and manufacturing of products with adherence to industry & GMP standards.
• Manage design history file (DHF) including design review meetings, phase sign-offs, and ensures seamless transition to manufacturing.
• Develop and maintain the design control process (DMR, DHF, Technical Files, etc.)
• Research new technologies to develop design concepts. Leads group ideation sessions. Creates drawings, supporting documentation, and develops product specification for new products designs.
• Research/evaluate new technologies that can contribute to future product development and increase product pipeline.
• Produce design models, drawing details, assembly drawings, and associated engineering documentation with 3-D parametric modeling software, MS Word, EXCEL and MS Power Point.
• Ideate/lead continuous improvement initiatives focused on current product performance and costs.
• Direct final product verification and validation.
• Maintain all documentation for existing products.
• Develop and keep current work instructions, travelers, drawings, labeling, etc. based on knowledge of changing regulatory requirements.
• Manage the new product introduction process from conceptualization through introduction to manufacturing.
• Provide technical leadership and strategic direction for the new product development process.
• Liaise with customers and commercial teams to define product introduction (NPI) requirements. Ensures that NPI activities fulfill requirements.
• Work with KOL’s to assure both design and voice of customer (VOC) requirements are properly carried out.
• Develop test methods for new products and utilizes test data to iterate on product designs and author industry white papers.
• Research new sterilization, material characterization, cleaning validations, metrology, and inspection techniques.
• Ensure compliance in all aspects of Environmental, Health and Safety per industry standards and local regulations.

Software

• Own software and controls for manufacturing applications; supports development of customer-facing applications/products. Full scale leadership on applicable projects.
• Translate physical manufacturing workflow requirements and customer requirements to software requirements.
• Design, develop, debug, maintain, and document software components. Develops software to ensure formatting is transferrable across multiple applications and processes.
• Design solutions for SLA, 3D Printing, CNC Milling, Laser Marking and Laser Trimming, X-Ray Tomography, and manufacturing systems integration with commercial software system ERP, MES and data warehousing systems.
• Define User Acceptance Testing scenarios and protocols.
• Design and executes validation protocols (IQ, OQ, PQ) for the site for complex change programs to 21 CFR Part 11 compliance.
• Lead the design and implementation of Application Programming Interfaces (APIs).
• Integrate multiple components from various sources into software applications.
• Draft high-level technical architecture with external partners.
• Identify inefficiencies in current system architectures and works to rebuild them.
• Research new technologies and software development practices.

Electro/Mechanical

• Perform the design and assembly of devices and equipment that blend electrical and mechanical components.
• Support and/or leads the development of equipment and devices at all stages, from concept creation to production tooling.
• Aim to optimize safety, economy, reliability, sustainability, and quality.
• Design equipment component replacements/additions to improve machine and process efficiency. Performs small-scale machine retrofits.
• Make adjustments and improvements to existing equipment to improve efficiency.
• Design and implements mid-scale automation solutions and semi-automated subassemblies.
• Ensure maintenance on equipment within multiple areas is up-to-date.
• Provide technical support for control systems utilized in the multiple areas. Designs/builds small-scale control systems.
• Generate accurate and controlled documents pertaining to process equipment.
• Research the latest technology and looks to implement in current equipment/processes.

SPECIFIC KNOWLEDGE & SKILLS:

• Bachelor’s or Masters Degree in Engineering (Mechanical, Chemical, Physics, Computer sciences)
• Ability define documents such as operating and maintenance instructions, technical drawings, industrial standards and procedure manuals
• Ability to write technical reports and technical correspondence with management. Ability to review and critique junior engineers reports.
• Detail oriented, and ability to organize, document and communicate across the organization.
• 5 years Medical or dental device manufacturing working experience
• Advanced Knowledge of regulatory requirements (FDA and others)
• High level of proficient in GMP quality standards
• Experience of executing Six Sigma and Lean Manufacturing projects and deployment and training of these concepts
• Proficient in new product development processes from concept through full production release
• Experience leading large scale projects in a manufacturing environment. The ability to manage project cost and keep withing defined budget
• Experience in research projects and product conceptualization

GENERAL SKILLS & COMPETENCIES:

• Excellent understanding of industry practices
• Strong proficiency with tools, systems, and procedures
• Strong planning/organizational skills and techniques
• Strong decision making, analysis and problem-solving skills with ability to multi-task
• Excellent verbal and written communication skills
• Strong presentation and public speaking skills
• Strong interpersonal skills
• Strong conflict resolution skills and ability to deliver difficult messages
• Ability to build partnerships at all levels within the company, ability to build partnerships externally
• Good negotiating skills
• Resolve complex issues in effective ways
• Project management, consultative skills and ability to manage a budget

MINIMUM WORK EXPERIENCE:

Typically 6 to 8 or more years of increasing responsibility in terms of any applicable professional experience.

PREFERRED EDUCATION:

Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent a plus. May hold one or more industry certifications.

TRAVEL / PHYSICAL DEMANDS:

Travel typically less than 10%. Office environment. No special physical demands required.