Mechanical Engineer

Industry: Medical Equipment / Devices

Job Category: Engineering - Industrial / Manufacturing

Duties and Responsibilities:

• Work closely with maintenance technicians to provide technical support, identify critical problem areas, and perform troubleshooting across multiple automated production lines
• Ability to design and redesign mechanical systems for automated production, to include linear motion, pneumatics, vacuum systems, visions systems, labelers, pick and place modules, fixturing, locating, and general conveyance of the product
• Application of Transfer functions during troubleshooting and production support (i.e. Statistical Tolerance Analysis, Design for Six Sigma) - Ability to utilize a set of existing tools to aid in the analysis of parts and subsystems
• Understanding of Manufacturing Statistical methods, such as process capability and Design of Experiments - Understands and can apply limited statistical tools used to assist in development and troubleshooting of products and processes.
• Project Management leadership in areas focusing on design changes, process improvements, outsourcing, material cost reduction, and other plant efficiency efforts. - Ability to identify project requirements and develop schedules with significant assistance from more senior level engineering
• Core Team Member Representation in assigned plant - Basic understanding the NPI process and can execute plans with the guidance of a more senior level engineer
• Implementation of BD Processes, which include Deviations, Engineering Change Orders - Ability to identify project requirements and develop schedules with significant assistance from more senior level engineering
• CAPA Execution - Understands the process and can complete CAPA activities with significant guidance from an SME
• Engineering Standards such as ASME Y15.4 - Understands and can apply some elements of various standards to engineering drawings. Typically requires oversight from a more senior level engineer
• ISO compliance, FDA 21 CFR 820 compliance, and cGMP efforts - Understands and has knowledge of FDA and ISO regulations and cGMP. Requires oversight from SME to ensure compliance in all applicable areas
• Computer Aided Design work - Functional with Solidworks and AutoCad. Ability to effectively create models, assemblies, and drawings with some guidance from SME.
• Geometric Dimensioning and Tolerancing Firm understanding and application of many GD&T specifications. Requires some guidance from SME.
• Technical Writing skills as applied to manufacturing documentation and process development - Experienced in the creation and revision of technical documentation. Receives little guidance from SME
• Agency Compliance (General knowledge) - Familiar with general UL, CSA, and CE requirements.
• Obsolescence Management - Can perform design analysis and replacement activities for basic components.
• Carries out all other duties and responsibilities as assigned.

Knowledge and Skills:

• Able to organize and prioritize assignments as a participant to assigned functional teams (minimum 2 years working in a team environment).
• Demonstrates excellent written and verbal communication skills across all levels.
• Ability to represent functional and operations organization with clarity
• Supports and drives change management within function
• Functional or cross functional liaison with stakeholders concerning operational or project deliverables.
• Ability to manage customer satisfaction initiatives.
• General knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO); minimum 1 year working in a regulated environment

Skills and Certifications [note: bold skills and certification are required]
Diagnose and troubleshoot manufacturing/production lines
Prefer to have managerial experience

Security Clearance Required: No

Visa Candidate Considered: No

Compensation

Base Salary - USD $90,000 to $100,000

*** Never repost ***

Full-time

Benefits - Full

Relocation Assistance Available - No

Commission Compensation - No

Bonus Eligible - No

Overtime Eligible - No

Interview Travel Reimbursed - No

Candidate Details

2+ to 5 years experience

Seniority Level - Mid-Senior

Management Experience Required - No

Minimum Education - Bachelor's Degree

Willingness to Travel - Never

Ideal Candidate
We are not looking for Design Engineers. Ideally a Mechanical Engineer with Manufacturing experience. Ability to diagnose and troubleshoot manufacturing issues a must. Lead projects and manage technicians.

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Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It s also a place where we help each other be great, we do what s right, we hold each other accountable, and learn and improve every day.