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Engineering and Manufacturing

Manufacturing Engineer Medical Device Implantable
The Manufacturing Engineer leads initiatives for the daily support of products, processes, and equipment and may be responsible for leading the integration of new products within production, meeting new product integration timelines and production goals (i.e., safety, quality, delivery, cost, and productivity)

Job Duties and Responsibilities (Essential Functions)• This individual will be required to routinely partner with cross-functional teams to evaluate, troubleshoot and implement manufacturing processes within the business unit.• Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.• Prepares reports, publishes, and makes presentations to communicate findings.• Understands engineering principles theories, concepts, practices and techniques.• Incorporates business policies and procedures into task completion.• May lead a project team, determining goals and objectives for the projects.• Successfully contributes to both new product development teams and product support, including the following activities: process capability studies, process development, report preparation and process/test documentation.• Identifies, implements, and manages equipment requirements to support production goals.• Is a positive agent for change, not bound by the way things are or have always been done.• Takes initiative to identify improvement opportunities, prioritize them, communicate them to the appropriate levels and sees them through to completion.

Required Skills and Experience (Minimum requirements in terms of educational background, work experience, licenses/certifications or other knowledge, skills, and abilities).• Manufacturing, mechanical, or industrial engineering degree or equivalent.• 0-2 years’ experience working in a manufacturing environment (preferably medical device industry).• Must be able to speak, read and communicate English clearly.• Must be able to write English legibly.• Must be well versed in Microsoft Office (Excel, PowerPoint, etc.).
Additional Skills and Experience (Preferred or helpful)• Solidworks experience is a plus • Should be open to continuing education

Quality Engineer Implantable Medical Devices
Provide quality support to customers, suppliers, manufacturing engineers, inspection and production personnel to ensure products and processes conform to customer and regulatory requirements.  Generate and maintain metrics to identify continual improvement opportunities. Job Duties and Responsibilities (Essential Functions) Collect, review, analyze and publish corrective action and non-conformance data in an effort to eliminate non-conformances.   Develop and maintain working relationships with Engineering, Quality Systems, Inspection and Manufacturing personnel to facilitate group problem solving and cooperation.

Understand and provide support for quality requirements as needed including, certificates of conformance, sampling inspections, first articles inspections, process approval, inspection plans, test and inspection reports, PFEMA, and control plans. • Support the completion and maintenance of risk analysis and complaint evaluations. • Lead the investigation to resolve customer complaints and in the prevention of product non conformances. • Develop reports and metrics on various aspects of product assurance function including the cost of scrap and rework operations, the accuracy of inspection, quality of outgoing product, etc. Monitor nonconforming parts through RMA and the rework process including timely disposition and closure. • Support the auditing and evaluation process to assure conformance to established standards, specifications, and customer requirements.  • Prepare reports and make recommendations for corrective or preventative action to improvement product quality.  Implement action to be taken and follow up for effectiveness to eliminate or prevent non conformances and their causes.   • Assist with the development of inspection processes and operation instructions    • Assist the internal audit program to measure the overall effectiveness of the quality management system.

Required Skills and Experience (Minimum requirements in terms of educational background, work experience, licenses/certifications, or other knowledge, skills, and abilities).• Bachelor’s degree in Engineering or related discipline. • Minimum 5 years of experience in a related role and industry sector. • Proficient reading, writing, oral communication, and comprehension in the English language.  • Knowledge of industrial math.• Knowledge and working experience with MS Office, (Word, Excel, Power-Point, Project).  Knowledge of computer integrated manufacturing software including accessing and retrieving information using the computer.  • Expertise with data and defect analysis, variance reduction, and capability analysis.• Strong knowledge in the application of Quality Systems.• Understanding of internal auditing methods and quality system procedures.• Understanding of Process Failure Mode Effect Analysis and control plan.• Working knowledge of quality at the source techniques, root cause analysis, corrective action, continuous improvement.• Ability to interpret engineering drawings.• Strong organizational and project management skills.  • Ability to understand quality issues and assist staff in root cause problem solving to effectively meet customer needs.• Strong interpersonal skills and demonstrated ability to work effectively within the organization and collaborate with internal and external clients to determine requirements and eliminate any barriers that may affect the quality and delivery of the product. Additional Skills and Experience (Preferred or helpful)• Experience working in the Medical Device industry, specifically ISO 13485:2016 and FDA 21 CFR 820.• ASQ Certified CCT preferred or CQE desired or willing to obtain.• Familiar with ANSI/NCSL Z540-01 and ISOIEC17025 a plus.• Experience working with M1 ERP system or similar• Ability to work well with little supervision• Must be a well-organized problem solver.• Possess the ability to make rational knowledge-based decisions.

Electrical Designer

Will work on the design of electrical power distribution and lighting systems for commercial buildings and industrial/manufacturing facilities. Commercial project work scopes include tenant improvement/refurbishment of building lighting and power apparatus, communicating electric service requirements with the Utility company, developing one-line or riser diagrams, design and specification of lighting and lighting controls, including emergency systems, and coordinating electrical design to support building environmental and plumbing systems. Industrial/Agriculture project work includes development of: Grounding plans, Hazardous area plans, Site and building specific lighting plans, Power plans including cable tray, conduit and underground ducts, Power and instrument plans, one-line diagrams and panelboard schedules. Most of this work will be completed in 3D and in Revit (BIM360).

Responsibilities: Layout plans, sections and details to specified CAD standards.  Identify redlines on drawings created by others and accurately make required changes.  Coordinate plotter maintenance and project archiving as requested.  Occasional travel to construction job sites.

Additional Designer Responsibilities: Provide direction and distribute work to Technicians.  Review and back-check Technician’s work.  Coordinate with design team members and product vendors.  Communicate with clients and/or contractors regarding RFI’s and field questions.  Maintain awareness of fees and drafting time, understand project scope and identify potential additional service items.  Review shop drawings.  Attend internal coordination meetings and client coordination meetings as needed.

Minimum Qualifications: Certificate in construction related design/drafting or higher and at least three years of directly related experience OR at least four years of directly related REVIT experience preferred, Understanding of the National Electrical Code (NEC) preferred.

Entry Level Mechanical Engineer

Will design material handling, process ventilation and building safety systems, process and utility piping and heat exchangers, and building HVAC and plumbing systems for agribusiness, industrial and commercial facilities.

Responsibilities: Perform high quality engineering services.  Assist with the preparation of high-quality construction documentation including calculations, drawings and specifications.  Efficiently use appropriate software to complete engineering design. Potential 5% travel to construction job sites.

Minimum Qualifications: BS, Mechanical Engineering  0-5 years engineering experience HVAC, Plumbing and REVIT modeling experience preferred.

Qualifications: 2 – 5 years’ experience E.I.T. BENEFITS: Hybrid work environment, competitive compensation, medical, dental, vision, disability, 401(k), profit-sharing, paid holidays, PTO, wellness programs, LinkedIn Learning subscription, paid parental leave, professional development opportunities and more.

Buildings Entry/Mid-Level Structural Engineer – Buildings Analytical, accurate, independent…does this sound like you? Are you looking for an established firm that provides opportunities for professional growth and training in a fast-paced environment? We’re looking for a dedicated, detail-oriented professional to consistently deliver to our clients. Our customer provides engineering and design services for commercial projects in a variety of markets including retail, corporate, hospitality, government and manufacturing.

Responsibilities:• Perform high quality engineering services.  Appropriately and efficiently use software and hand calculations to develop design solutions that meet code requirements and are constructible.  Perform site visits/observations/structural evaluations. (Potential 10% travel to construction job sites.)Additional Responsibilities for Engineers with 5 or more years of experience: Lead the preparation of proposals, design documents and project deliverables.  Coordinate design team effort internally and externally. Develop and coordinate project details.

Minimum Qualifications: Bachelor’s degree in civil engineering with structural engineering emphasis Additional Qualifications for Engineers with 5 or more years of experience: Licensed Professional Engineer (PE)Preferred Qualifications: E.I.T. for entry-level position MS, Engineering• LEED accreditation

BENEFITS: Flexible work, competitive compensation, medical, dental, vision, disability, 401(k), profit-sharing, paid holidays, PTO, wellness programs, flexible schedules, LinkedIn Learning subscription, paid parental leave, professional development opportunities and more.

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