Sr. Engineer

We are seeking an experienced Engineer<\/b> to support the design, development, and integration of automated assembly and packaging equipment in a regulated manufacturing environment.

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Key Responsibilities<\/span b span>

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Assist in developing <\/span>User Requirement Specifications (URS)<\/span b> and mechanical/electrical designs for equipment.

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Support equipment integration, including <\/span>FAT, SAT, installation, and startup<\/span b>.

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Ensure equipment and process designs meet <\/span>product, safety, and operational requirements<\/span b>.

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Collaborate with vendors and suppliers on <\/span>capital projects<\/span b>, managing scope, cost, and timelines.

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Support <\/span>vendor contracts<\/span b> in partnership with procurement and legal teams.

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Develop or obtain <\/span>CAD models and technical drawings<\/span b> (2D/3D).

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Maintain design documentation (URS, assembly instructions, bills of process, etc.).

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Optimize equipment for <\/span>efficiency, cost, manufacturability, and ease of operation/maintenance<\/span b>.

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Participate in <\/span>design reviews, risk assessments, and FMEA<\/span b> activities.

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Work with manufacturing teams to <\/span>build, test, and improve prototypes<\/span b>.

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Perform or support engineering analyses (stress, thermal, fluid, etc.).

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Collaborate with cross -functional teams (engineering, maintenance, etc.) for system integration.

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Ensure compliance with <\/span>safety, quality, GMP, and regulatory standards<\/span b span span>

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Requirements<\/h3>

Minimum Qualifications<\/span b span>

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Ability to work independently and develop solutions with minimal supervision.

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Experience in <\/span>tooling design and complex mechanical systems<\/span b> (preferred).

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Knowledge of <\/span>PLC programming and controls<\/span b>.

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Proficiency in <\/span>AutoCAD and/or SolidWorks<\/span b>.

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Strong skills in <\/span>project management, organization, and planning<\/span b>.

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Experience with <\/span>problem -solving and data analysis<\/span b>.

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Familiarity with <\/span>GMP, ISO standards, Lean Manufacturing<\/span b>, and <\/span>FDA -regulated environments<\/span b> (preferred).

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Experience with <\/span>risk analysis (FMEA) and statistical tools (SPC)<\/span b>.

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Ability to manage <\/span>multiple priorities and project timelines<\/span b>.

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Strong communication skills.

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Willingness to travel up to <\/span>25 span b> (domestic and international).

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Education<\/span b span>

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Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related).

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Equivalent hands -on experience may be considered.

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Experience<\/span b span>

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Minimum <\/span>8 years of engineering experience<\/span b>.

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Background in <\/span>automated manufacturing equipment and high -volume production<\/span b>.

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Experience in <\/span>medical devices, pharmaceuticals, or in -vitro diagnostics<\/span b> (preferred).

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Proven experience in: <\/span>

Process improvements

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Equipment implementation and validation

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Full project lifecycle (scoping, budgeting, vendor management, installation, validation)

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Knowledge of <\/span>labeling, barcode systems, and packaging cost analysis<\/span b>.

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Physical Requirements<\/span b span>

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Ability to sit or work on a computer for extended periods (up to 8 hours).

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Ability to stand for long periods during testing, FAT/SAT, and troubleshooting.

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Ability to move within manufacturing environments (climbing, squatting, etc.).

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Must comply with <\/span>PPE and GMP requirements<\/span b> in a regulated facility.

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Special Skills span span b>

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Proficient in CAD, WORD, Excel, MS Project. Working knowledge of Minitab is a plus span>

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Benefits<\/h3>

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